The Medical Device Single Audit Program (MDSAP) is an initiative by the International Medical Device Regulators Forum (IMDRF) to develop a harmonized audit program that allows medical device manufacturers to undergo a single regulatory audit to satisfy the requirements of multiple regulatory jurisdictions. The MDSAP pilot program began in 2014 and involves regulators from the US, Canada, Brazil, Australia and Japan. It aims to recognize third-party auditing organizations to conduct audits of medical device manufacturers according to a standardized audit process, with the goal of facilitating medical device trade while ensuring public health and safety.
Presentation: Medical Devices Single Audit Program (MDSAP) Pilot ProgramTGA Australia
This presentation provides an update on the progress of the Pilot and explores how the results of audits will be used by the participating Regulatory Authorities in support of market authorisation within their jurisdictions.
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...Greenlight Guru
The Medical Device Single Audit Program (MDSAP) is an international initiative spearheaded by the International Medical Device Regulatory Forum (IMDRF) to develop a standardized global approach to auditing and inspecting of medical device manufacturers that will be accepted by multiple regulators to address QMS/GMP requirements.
Although the program has seen relatively low participation to date, the promise to help reduce compliance cost for device makers by eliminating the need for multiple quality system audits and inspections means there is much to be gained by industry from a successful implementation the program.
This presentation will cover:
-Understand the goals and benefits of the MDSAP program
-What are the main differences between MDSAP and standard auditing
-How to benchmark your QMS against the MDSAP
-How the new non-conformance grading system works
-How to prepare your company for a successful MDSAP implementation
Watch the presentation here: https://www.greenlight.guru/webinar/medical-device-single-audit-program-mdsap
The document discusses upcoming changes to regulatory requirements for medical devices, including:
1) The MDSAP program which allows a single audit to satisfy multiple regulators like FDA, EU, Japan, Australia. Major auditing organizations have been recognized to conduct MDSAP audits.
2) Revisions to ISO 13485:2016 including greater risk focus, regulatory linkage, and design/development changes. Manufacturers must transition to the new standard by March 2019.
3) Changes to the MEDDEV 2.7.1 clinical evaluation guidance including more frequent evaluations based on risk class and new requirements for team qualifications and establishing state of the art.
4) The upcoming EU Medical Device Regulation which replaces the Medical
ISO 13485 is the medical industry's optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings.
ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements.
This implementation guide will help you run through the benefits and clauses in detail for implementing ISO 13485.
Find out more or get a quote for certification here – https://www.nqa.com/en-gb/certification/standards/iso-13485
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. The standard focuses on meeting customer and applicable regulatory requirements and is intended for any organization partially or fully involved in the medical device life-cycle.
This presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 13485:2016 standard. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors in the medical devices industry.
It covers the what and why of ISO 13485, the QMS key clause structure, the audit approach and also offers practical tips on how to handle an audit session. When you are done teaching this material to your employees, they will be much more informed and comfortable with ISO 13485:2016.
LEARNING OBJECTIVES
1. Provide background knowledge on ISO 13485:2016
2. Gain an overview of ISO 13485:2016 structure and the certification process
3. Understand the audit approach
4. Gather useful tips on handling an audit session
CONTENTS
1. Overview of ISO 13485
About ISO
What are Standards?
Why are Standards Important?
What is ISO 13485?
Who is ISO 13485 For?
What is a Medical Device?
What is a Quality Management System?
How Does ISO 13485 Work?
Benefits that ISO 13485 Will Bring to the Organization
Advantages of Certification
Development of ISO 13485
Why Was ISO 13485 Revised?
Key Improvements to ISO 13485:2016
Relationship of ISO 13485 with ISO 9001
2. ISO 13485:2016 Structure
The ISO 13485:2016 Structure
The Plan-Do-Check-Act (PDCA) Process Model
ISO 13485:2016 Approach is Based on the PDCA Cycle
Documentation Requirements
ISO 13485:2016 Key Clause Structure (4-8)
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis & Improvement
3. ISO 13485:2016 Certification
Becoming ISO 13485:2016 Certified
ISO 13485:2016 Certification Process
4. Audit Approach
What is a Quality Audit?
What Are Audits Used For?
Types of Quality Audits
Internal Quality Audit
Principles of Auditing
Audit Focus
Audit Approach
Audit Emphasis
Document Review
Audit Findings
5. Handling an Audit Session
Rights of Auditee
Rights of Auditor
How to Handle an Audit Session?
Auditee's Conduct
Interacting with Auditors: Do's
Interacting with Auditors: Don'ts
Explanation of ISO standard 13485 (QUALITY MANAGEMENT SYSTEM OF MEDICAL DEVICES) in a clarified way to understand it well in a simplified way through this mode. Your comments are appreciated.
Understanding the New ISO 13485:2016 RevisionGreenlight Guru
he much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late last month (Feb, 2016).
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here (http://www.greenlight.guru/webinar/iso-13485-2016-changes).
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-transition-planning)
In this webinar, you'll learn specifically:
What your organization needs to be doing to prepare for the transition to ISO 13485:2016
Why the transition presents an opportunity for your organization to implement better processes
An overview of the specific changes coming with ISO 13485:2016
The actions you should be taking now and how to plan for the implementation of the standard
Presentation: Medical Devices Single Audit Program (MDSAP) Pilot ProgramTGA Australia
This presentation provides an update on the progress of the Pilot and explores how the results of audits will be used by the participating Regulatory Authorities in support of market authorisation within their jurisdictions.
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...Greenlight Guru
The Medical Device Single Audit Program (MDSAP) is an international initiative spearheaded by the International Medical Device Regulatory Forum (IMDRF) to develop a standardized global approach to auditing and inspecting of medical device manufacturers that will be accepted by multiple regulators to address QMS/GMP requirements.
Although the program has seen relatively low participation to date, the promise to help reduce compliance cost for device makers by eliminating the need for multiple quality system audits and inspections means there is much to be gained by industry from a successful implementation the program.
This presentation will cover:
-Understand the goals and benefits of the MDSAP program
-What are the main differences between MDSAP and standard auditing
-How to benchmark your QMS against the MDSAP
-How the new non-conformance grading system works
-How to prepare your company for a successful MDSAP implementation
Watch the presentation here: https://www.greenlight.guru/webinar/medical-device-single-audit-program-mdsap
The document discusses upcoming changes to regulatory requirements for medical devices, including:
1) The MDSAP program which allows a single audit to satisfy multiple regulators like FDA, EU, Japan, Australia. Major auditing organizations have been recognized to conduct MDSAP audits.
2) Revisions to ISO 13485:2016 including greater risk focus, regulatory linkage, and design/development changes. Manufacturers must transition to the new standard by March 2019.
3) Changes to the MEDDEV 2.7.1 clinical evaluation guidance including more frequent evaluations based on risk class and new requirements for team qualifications and establishing state of the art.
4) The upcoming EU Medical Device Regulation which replaces the Medical
ISO 13485 is the medical industry's optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings.
ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements.
This implementation guide will help you run through the benefits and clauses in detail for implementing ISO 13485.
Find out more or get a quote for certification here – https://www.nqa.com/en-gb/certification/standards/iso-13485
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. The standard focuses on meeting customer and applicable regulatory requirements and is intended for any organization partially or fully involved in the medical device life-cycle.
This presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 13485:2016 standard. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors in the medical devices industry.
It covers the what and why of ISO 13485, the QMS key clause structure, the audit approach and also offers practical tips on how to handle an audit session. When you are done teaching this material to your employees, they will be much more informed and comfortable with ISO 13485:2016.
LEARNING OBJECTIVES
1. Provide background knowledge on ISO 13485:2016
2. Gain an overview of ISO 13485:2016 structure and the certification process
3. Understand the audit approach
4. Gather useful tips on handling an audit session
CONTENTS
1. Overview of ISO 13485
About ISO
What are Standards?
Why are Standards Important?
What is ISO 13485?
Who is ISO 13485 For?
What is a Medical Device?
What is a Quality Management System?
How Does ISO 13485 Work?
Benefits that ISO 13485 Will Bring to the Organization
Advantages of Certification
Development of ISO 13485
Why Was ISO 13485 Revised?
Key Improvements to ISO 13485:2016
Relationship of ISO 13485 with ISO 9001
2. ISO 13485:2016 Structure
The ISO 13485:2016 Structure
The Plan-Do-Check-Act (PDCA) Process Model
ISO 13485:2016 Approach is Based on the PDCA Cycle
Documentation Requirements
ISO 13485:2016 Key Clause Structure (4-8)
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis & Improvement
3. ISO 13485:2016 Certification
Becoming ISO 13485:2016 Certified
ISO 13485:2016 Certification Process
4. Audit Approach
What is a Quality Audit?
What Are Audits Used For?
Types of Quality Audits
Internal Quality Audit
Principles of Auditing
Audit Focus
Audit Approach
Audit Emphasis
Document Review
Audit Findings
5. Handling an Audit Session
Rights of Auditee
Rights of Auditor
How to Handle an Audit Session?
Auditee's Conduct
Interacting with Auditors: Do's
Interacting with Auditors: Don'ts
Explanation of ISO standard 13485 (QUALITY MANAGEMENT SYSTEM OF MEDICAL DEVICES) in a clarified way to understand it well in a simplified way through this mode. Your comments are appreciated.
Understanding the New ISO 13485:2016 RevisionGreenlight Guru
he much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late last month (Feb, 2016).
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here (http://www.greenlight.guru/webinar/iso-13485-2016-changes).
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-transition-planning)
In this webinar, you'll learn specifically:
What your organization needs to be doing to prepare for the transition to ISO 13485:2016
Why the transition presents an opportunity for your organization to implement better processes
An overview of the specific changes coming with ISO 13485:2016
The actions you should be taking now and how to plan for the implementation of the standard
Japan PMDA Medical Device Regulatory Approval ProcessEMERGO
Watch the recorded webinar: https://www.emergogroup.com/resources/video-webinar-japan-registration-process
Japan's medical device market is one of the most robust markets in Asia, but its regulatory system can be confusing. Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply to your device, which steps to take, and what resources are required to complete the process. In this presentation, Ann Marie Boullie, Vice President of Business Development for EMERGO, will discuss some of the most complex aspects of the Japanese registration process, including:
JMDN codes: device classification and predicates
Clinical data requirements and PMDA pre-submission meetings
Registration routes (Todokede, Ninsho, Shonin)
QMS (Ordinance 169) requirements
Role of the Marketing Authorization Holder (MAH)
Plus more ...
Introduction
Definition
Classification
Regulatory registration procedure
Quality system requirements
Clinical evaluation
Investigation of medical devices
Summary
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration (CFDA)
Manufacturers must register their devices with the NMPA before selling or distributing in China.
The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of compensation for an injury or handicap conditions
Investigation, replacement or modification for anatomy or a physiological process
Control of conception
The Chinese authorities (CFDA/NMPA) have their own quality management system requirements.
However, these “GMP requirements” are very similar to ISO 13485.
Therefore, manufacturers usually submit the ISO 13485 certificate.
However, the audit will review this certificate against the Chinese GMP requirements.
These audits are regularly carried out during the approval procedure and/or after a recall.
NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.
Product Life-cycle Process
The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. Applicant needs to:
Ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
Carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
For lower-risk medical devices (Class I and Class II), clinical evaluation may not always be required. However, higher-risk devices (Class III and implantable devices) generally require clinical evaluation.
The evaluation involves reviewing existing clinical data, scientific literature, and relevant clinical research to assess the safety and performance of the device.
All clinical trials for medical devices must follow China Good Clinical Practices
Clinical investigations are required if no equivalent devices can be found and safety and efficacy cannot be proven with other clinical and non-clinical data.
For certain medical devices, the NMPA may require clinical investigations, especially for novel devices or those with significant risk.
Clinical investigations involve conducting studies on human subjects to generate clinical data on the safety and effectiveness of the device.
This presentation consist of what ISO 13485 is and why is it important to consider this standard while designing a medical device. It will help u understand what Quality actual is and its importance in medical device industry. It gives you insight about quality management system and its documentation.
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
ISO 13485 certification ensures the quality and safety of medical devices by requiring companies to follow an international quality management standard. It helps companies attract more contracts by providing a globally recognized guarantee of their medical device products and quality systems. URS Group is an accredited certification body that provides ISO 13485 certification and other services to assess organizations' management systems, audits, trainings, and product certification on a global scale. They are a reputable choice for ISO 13485 certification due to their international accreditation and worldwide network.
Differences Between ISO 13485 and ISO 9001riteshreddych
ISO 13485:2003 includes specific requirements for quality management systems in the medical device industry. It harmonizes with regulatory requirements like the Quality System Regulation (QSR). Key differences from ISO 9001:2000 include a stronger focus on regulatory compliance, process documentation, traceability, and risk management in product design. The document discusses the reasons for adopting ISO 13485 over ISO 9001 for medical device manufacturers.
This presentation consist of what ISO 14971 is and why is it important to consider this standard while designing a medical device or any device for that matter. It will help u understand what Risk actual is and importance of risk management in medical device industry. It gives you insight about Risk management technique. You will Understand FMEA and how to use it.
ISO 13485 outlines quality management system requirements for medical device manufacturers. It requires organizations to establish documented processes for planning and managing key activities like risk management, product realization, and quality improvement. Records must be maintained to demonstrate conformity to standards. Management is responsible for ensuring adequate resources, communication of quality policies, and regular reviews of the quality system and opportunities for improvement.
The document summarizes regulatory considerations for pharmaceuticals in Japan, including manufacturing, packaging, labeling, and post-marketing surveillance. For manufacturing, drugs must be approved by the Ministry of Health, Labor and Welfare and manufacturers must be licensed and follow good manufacturing practices. Packaging and labeling must contain specified information and any changes require relabeling. Post-marketing surveillance involves adverse event reporting, drug reexaminations every few years to reconfirm safety and efficacy, and reevaluations based on current medical knowledge.
This document provides guidance on preparing for an FDA pre-approval inspection. It discusses what to expect during an inspection, including that inspectors will review documentation for compliance with quality standards. It stresses the importance of managing the inspection through preparation, including conducting internal audits and training personnel. It also recommends designating an inspection team to guide the process and handle document requests. The overall goal is to demonstrate control over quality issues to avoid delays in approval.
Brazil medical device registration and approval chart - EMERGOEMERGO
Brazil has a classification system for medical devices with four classes - I, II, III, and IV. Class I and II devices require a simplified registration called a Cadastro, while Class III and IV devices require a more rigorous registration called a Registro. To register a device, a company must appoint a Brazil Registration Holder to submit the application to ANVISA and obtain necessary approvals. Certain devices may also require certification from inspection agency INMETRO. The registration process can take 1-3 months for Classes I and II or 8-15 months for Classes III and IV, though Class III and IV can take over 4 years if additional inspections are required.
The document provides guidance on the Plasma Master File (PMF) certification process and evaluation of transmissible spongiform encephalopathy (TSE) and bovine spongiform encephalopathy (BSE) risk. It outlines the PMF submission and evaluation procedure, including the use of an electronic common technical document format. It also describes TSE and BSE as rare brain diseases caused by prion proteins, and the regulatory compliance and risk assessment measures taken to prevent transmission through pharmaceutical and biological products derived from animal sources.
This presentation is an overview of the Medical Device Regulatory Process for China. I used this to teach about SFDA Order No. 27, the amendments, Order No. 15 (Classification), Order No. 16 (Registration), YY, GB, YY/T, GB/T, YZB standards and the different registration forms to use for devices made in People\'s Republic of China, about imported medical devices, and about devices allowed from Taiwan, Hong Kong and Macau regions.
ISO 13485:2016 Transition Are You Prepared - OMTEC 2017April Bright
ISO 13485:2016 will apply across the whole supply chain and will address the entire lifecycle of a medical device. Key changes to the standard include harmonization of regulatory requirements; inclusion of risk management throughout the QMS; additional clarity with regard to validation, verification and design activities; strengthening of supplier control processes; increased focus regarding feedback mechanisms; software for QMS; manufacturing and the medical device. These changes require a well-thought-out plan for implementation by March 2019 and continuation of the standard thereafter.
This presentation will highlight the actions you should take now in order to successfully transition to the updated standard.
Medical devices – Quality management
systems – Requirements for regulatory
Purposes. ISO is an organization that develops Standards for use
worldwide.
ISO 13485 helps companies do their share in protecting
consumers and users of medical devices.
ISO 13485 Outlines criteria for a good Quality
Management System (QMS).
QMS criteria are good business practices ...
for example:
• Set Quality goals
• Ensure that regulations and other requirements are
understood and met
• Train employees
• Control your production processes
• Purchase from suppliers that can provide products that
meet your requirements
• Correct problems and make sure they do not happen again
The document provides guidance for regulatory audits of medical device manufacturers' quality management systems. It discusses the Global Harmonization Task Force (GHTF), which aimed to harmonize medical device regulations internationally. GHTF established 5 study groups, including Study Group 4 which focused on auditing strategies and developed guidance documents. The guidance covers establishing auditing procedures, auditor competencies, and conducting and documenting audits in a harmonized manner. It provides a framework for consistent regulatory audits of medical device quality systems across countries.
Medical Device Single Audit Program (MDSAP)EMMAIntl
In 2012, the International Medical Device Regulators Forum (IMDRF) developed the Medical Device Single Audit Program (MDSAP) to implement a harmonized and a global approach to audit medical device manufacturers. The program allows for MDSAP recognized organizations to conduct a single audit that satisfies the regulatory requirements of the countries participating in the program
MDSAP is a technique through which medical device makers may be inspected once for conformity with the different medical device markets standards and regulatory requirements. Multiple individual audits or inspections by participating regulatory bodies or their representatives are replaced by a single audit. As a result, the Medical Device Single Audit Program minimizes the overall number of audits or inspections and optimises the time and resources spent on audit operations for many medical device manufacturers.
https://mavenprofserv.com/mdsap/
Japan PMDA Medical Device Regulatory Approval ProcessEMERGO
Watch the recorded webinar: https://www.emergogroup.com/resources/video-webinar-japan-registration-process
Japan's medical device market is one of the most robust markets in Asia, but its regulatory system can be confusing. Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply to your device, which steps to take, and what resources are required to complete the process. In this presentation, Ann Marie Boullie, Vice President of Business Development for EMERGO, will discuss some of the most complex aspects of the Japanese registration process, including:
JMDN codes: device classification and predicates
Clinical data requirements and PMDA pre-submission meetings
Registration routes (Todokede, Ninsho, Shonin)
QMS (Ordinance 169) requirements
Role of the Marketing Authorization Holder (MAH)
Plus more ...
Introduction
Definition
Classification
Regulatory registration procedure
Quality system requirements
Clinical evaluation
Investigation of medical devices
Summary
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration (CFDA)
Manufacturers must register their devices with the NMPA before selling or distributing in China.
The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of compensation for an injury or handicap conditions
Investigation, replacement or modification for anatomy or a physiological process
Control of conception
The Chinese authorities (CFDA/NMPA) have their own quality management system requirements.
However, these “GMP requirements” are very similar to ISO 13485.
Therefore, manufacturers usually submit the ISO 13485 certificate.
However, the audit will review this certificate against the Chinese GMP requirements.
These audits are regularly carried out during the approval procedure and/or after a recall.
NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.
Product Life-cycle Process
The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. Applicant needs to:
Ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
Carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
For lower-risk medical devices (Class I and Class II), clinical evaluation may not always be required. However, higher-risk devices (Class III and implantable devices) generally require clinical evaluation.
The evaluation involves reviewing existing clinical data, scientific literature, and relevant clinical research to assess the safety and performance of the device.
All clinical trials for medical devices must follow China Good Clinical Practices
Clinical investigations are required if no equivalent devices can be found and safety and efficacy cannot be proven with other clinical and non-clinical data.
For certain medical devices, the NMPA may require clinical investigations, especially for novel devices or those with significant risk.
Clinical investigations involve conducting studies on human subjects to generate clinical data on the safety and effectiveness of the device.
This presentation consist of what ISO 13485 is and why is it important to consider this standard while designing a medical device. It will help u understand what Quality actual is and its importance in medical device industry. It gives you insight about quality management system and its documentation.
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
ISO 13485 certification ensures the quality and safety of medical devices by requiring companies to follow an international quality management standard. It helps companies attract more contracts by providing a globally recognized guarantee of their medical device products and quality systems. URS Group is an accredited certification body that provides ISO 13485 certification and other services to assess organizations' management systems, audits, trainings, and product certification on a global scale. They are a reputable choice for ISO 13485 certification due to their international accreditation and worldwide network.
Differences Between ISO 13485 and ISO 9001riteshreddych
ISO 13485:2003 includes specific requirements for quality management systems in the medical device industry. It harmonizes with regulatory requirements like the Quality System Regulation (QSR). Key differences from ISO 9001:2000 include a stronger focus on regulatory compliance, process documentation, traceability, and risk management in product design. The document discusses the reasons for adopting ISO 13485 over ISO 9001 for medical device manufacturers.
This presentation consist of what ISO 14971 is and why is it important to consider this standard while designing a medical device or any device for that matter. It will help u understand what Risk actual is and importance of risk management in medical device industry. It gives you insight about Risk management technique. You will Understand FMEA and how to use it.
ISO 13485 outlines quality management system requirements for medical device manufacturers. It requires organizations to establish documented processes for planning and managing key activities like risk management, product realization, and quality improvement. Records must be maintained to demonstrate conformity to standards. Management is responsible for ensuring adequate resources, communication of quality policies, and regular reviews of the quality system and opportunities for improvement.
The document summarizes regulatory considerations for pharmaceuticals in Japan, including manufacturing, packaging, labeling, and post-marketing surveillance. For manufacturing, drugs must be approved by the Ministry of Health, Labor and Welfare and manufacturers must be licensed and follow good manufacturing practices. Packaging and labeling must contain specified information and any changes require relabeling. Post-marketing surveillance involves adverse event reporting, drug reexaminations every few years to reconfirm safety and efficacy, and reevaluations based on current medical knowledge.
This document provides guidance on preparing for an FDA pre-approval inspection. It discusses what to expect during an inspection, including that inspectors will review documentation for compliance with quality standards. It stresses the importance of managing the inspection through preparation, including conducting internal audits and training personnel. It also recommends designating an inspection team to guide the process and handle document requests. The overall goal is to demonstrate control over quality issues to avoid delays in approval.
Brazil medical device registration and approval chart - EMERGOEMERGO
Brazil has a classification system for medical devices with four classes - I, II, III, and IV. Class I and II devices require a simplified registration called a Cadastro, while Class III and IV devices require a more rigorous registration called a Registro. To register a device, a company must appoint a Brazil Registration Holder to submit the application to ANVISA and obtain necessary approvals. Certain devices may also require certification from inspection agency INMETRO. The registration process can take 1-3 months for Classes I and II or 8-15 months for Classes III and IV, though Class III and IV can take over 4 years if additional inspections are required.
The document provides guidance on the Plasma Master File (PMF) certification process and evaluation of transmissible spongiform encephalopathy (TSE) and bovine spongiform encephalopathy (BSE) risk. It outlines the PMF submission and evaluation procedure, including the use of an electronic common technical document format. It also describes TSE and BSE as rare brain diseases caused by prion proteins, and the regulatory compliance and risk assessment measures taken to prevent transmission through pharmaceutical and biological products derived from animal sources.
This presentation is an overview of the Medical Device Regulatory Process for China. I used this to teach about SFDA Order No. 27, the amendments, Order No. 15 (Classification), Order No. 16 (Registration), YY, GB, YY/T, GB/T, YZB standards and the different registration forms to use for devices made in People\'s Republic of China, about imported medical devices, and about devices allowed from Taiwan, Hong Kong and Macau regions.
ISO 13485:2016 Transition Are You Prepared - OMTEC 2017April Bright
ISO 13485:2016 will apply across the whole supply chain and will address the entire lifecycle of a medical device. Key changes to the standard include harmonization of regulatory requirements; inclusion of risk management throughout the QMS; additional clarity with regard to validation, verification and design activities; strengthening of supplier control processes; increased focus regarding feedback mechanisms; software for QMS; manufacturing and the medical device. These changes require a well-thought-out plan for implementation by March 2019 and continuation of the standard thereafter.
This presentation will highlight the actions you should take now in order to successfully transition to the updated standard.
Medical devices – Quality management
systems – Requirements for regulatory
Purposes. ISO is an organization that develops Standards for use
worldwide.
ISO 13485 helps companies do their share in protecting
consumers and users of medical devices.
ISO 13485 Outlines criteria for a good Quality
Management System (QMS).
QMS criteria are good business practices ...
for example:
• Set Quality goals
• Ensure that regulations and other requirements are
understood and met
• Train employees
• Control your production processes
• Purchase from suppliers that can provide products that
meet your requirements
• Correct problems and make sure they do not happen again
The document provides guidance for regulatory audits of medical device manufacturers' quality management systems. It discusses the Global Harmonization Task Force (GHTF), which aimed to harmonize medical device regulations internationally. GHTF established 5 study groups, including Study Group 4 which focused on auditing strategies and developed guidance documents. The guidance covers establishing auditing procedures, auditor competencies, and conducting and documenting audits in a harmonized manner. It provides a framework for consistent regulatory audits of medical device quality systems across countries.
Medical Device Single Audit Program (MDSAP)EMMAIntl
In 2012, the International Medical Device Regulators Forum (IMDRF) developed the Medical Device Single Audit Program (MDSAP) to implement a harmonized and a global approach to audit medical device manufacturers. The program allows for MDSAP recognized organizations to conduct a single audit that satisfies the regulatory requirements of the countries participating in the program
MDSAP is a technique through which medical device makers may be inspected once for conformity with the different medical device markets standards and regulatory requirements. Multiple individual audits or inspections by participating regulatory bodies or their representatives are replaced by a single audit. As a result, the Medical Device Single Audit Program minimizes the overall number of audits or inspections and optimises the time and resources spent on audit operations for many medical device manufacturers.
https://mavenprofserv.com/mdsap/
The Medical Device Single Audit Program (MDSAP) is a harmonised approach to auditing and monitoring the quality management systems of medical device manufacturers on an international scale. The purpose of MDSAP is to establish, conduct and command a single audit program. This allows a single audit of a medical device manufacturer’s QMS which satisfies the requirements of multiple regulatory jurisdictions.
https://mavenprofserv.com/what-is-mdsap/
The Medical Device Single Audit Program (MDSAP) is a harmonised approach to auditing and monitoring the quality management systems of medical device manufacturers on an international scale. The purpose of MDSAP is to establish, conduct and command a single audit program. This allows a single audit of a medical device manufacturer’s QMS which satisfies the requirements of multiple regulatory jurisdictions.
https://mavenprofserv.com/what-is-mdsap/
https://mavenprofserv.com/mdsap/
Global Regulatory Outlook: 2017 and Beyond - OMTEC 2017April Bright
This document provides an overview of global regulatory trends in 2017 and beyond for medical devices. Key points include increased emphasis on clinical data and post-market surveillance across regions. The EU is transitioning to the new Medical Device Regulation which increases requirements for technical documentation and quality management systems. Notified Bodies face challenges meeting demand under new rules. The US 21st Century Cures Act aims to streamline approval of certain lower-risk devices and accessories. Single audits through the Medical Device Single Audit Program may replace some regulatory inspections globally.
Join industry expert, Danny Kroo, key takeaways from the session include: 1. What is MDSAP and when should you consider it? 2. How to prepare for an MDSAP certification audit 3. What are common nonconformities issued by auditing organizations
This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
This document summarizes the marketing authorization procedures and post-approval changes (variations) for medicinal products in the UK. There are three procedures for obtaining initial marketing authorization: the decentralized procedure, mutual recognition procedure, and centralized procedure. After approval, post-approval changes or variations can be made, categorized as either type I (minor), type II (major), or type III (line extension). Supporting documents must be submitted to the appropriate authority for review and approval of variations before they are implemented.
Clinical evaluation report cer in a more stringent regulatory- Pepgra HealthcarePEPGRA Healthcare
European regulatory framework has established rules that govern the development, manufacturing, and marketing of medical devices in the European market. Both European and non-European medical device manufacturer’s fall under the purview of the regulatory framework, which is established to
provide condence to the clinicians and the patients that the medical devices and the implantable devices used in the region have been validated for their potential benets and certied as safe for usage.
A compliant CER should support strong clinical evidence that your device achieves its intended purpose without exposing users and patients to risk. The CER must be based on clinical data, which may include clinical data from existing literature, clinical experience, clinical trials, or any combination of the three.
You are required to prepare and submit a clinical evaluation report with your technical file as part of the CE Marking/conformity assessment process. However, approach the CER as a standalone document.
PECB Webinar: Proposed changes for medical device quality management systems ...PECB
We will cover:
• Overview of proposed changes to ISO 13485:201X, MDSAP
• New EU regulations and unannounced audits
• New directions for QMS and regulatory audits
Presenter:
This webinar will be presented by Danny Kroo, the founder and principal consultant at Docusys Corporation.
Clinical evaluation and the latest 2016 guidelineGRCTS
This “General Guidance” document promotes a common approach to clinical evaluation for "medical devices regulated by directives 90/385/EEC and 93/42/EEC. It does not concern in vitro diagnostic devices. The depth and extent of clinical evaluations should be flexible and appropriate to the nature, intended purpose, and risks of the device in question.
The Medical Device Regulations 2012, the subsidiary legislations under the Medical Device Act 2012 (Act 737), has been approved by the Malaysian Minister of Health and has been published in the Gazette on 31st December 2012. The Regulations will come into operation simultaneously with Act 737 on 1st July 2013. And as specified in Act 737 a transition period of two years for medical device registration and one year for establishment licensing will be given to the industry before it is fully enforced.
What you need to know about the Pharmacovigilance guidelines for companies marketing drugs in India. A concise overview of the six modules in the Guidance Document and the responsibilities of the Marketing Authorization Holders.
13 Medical Device Single Audit Program (MDSAP) Working Group.pdfDeepaPansare
The document discusses the International Medical Device Regulators Forum (IMDRF) and its Medical Device Single Audit Program (MDSAP) Working Group. The IMDRF aims to strategically accelerate international regulatory convergence for medical devices. The MDSAP Working Group is developing a standard set of requirements for auditing organizations to conduct single audits of medical device manufacturers' quality systems. This involves creating recognition criteria for auditing organizations based on standards from ISO, the EU, Health Canada, Japan, the US FDA and others. The goal is to establish a single audit program to improve regulatory convergence.
International Overview & Future Medical Devices Regulationsmdbio2009
This document provides an overview of medical device regulations internationally, including in Canada, the United States, Europe, Australia, and Asia. It discusses key regulatory bodies and requirements in each region. It also summarizes Canada's 2007-2012 strategies to modernize its regulatory framework and program, strengthen human resources and funding, improve governance, and foster stakeholder partnerships. Recognition of standards and relationships between different quality systems are also covered. The presentation aims to help organizations understand and navigate international medical device regulations.
Modification after Initial Review and Transparency and Real-World Performance...EMMAIntl
The next installment in our blog series on Artificial Intelligence/ Machine Learning (AI/ ML) based Software as a Medical Device (SaMD) will cover points three and four of FDA’s proposed Total Product Lifecycle (TPLC) approach: modification after initial review and transparency and real-world performance monitoring...
Medical Device Registration in India_ A Comprehensive Guide.pdfPranshuCorpseed
The dynamic landscape of healthcare, the regulatory framework governing medical devices plays a pivotal role in ensuring the safety, efficacy, and quality of products in the market.
Canadian Medical Devices Conformity Assessment System(CMDCAS) - Training mate...Samantha Chen, CQA
This document provides an overview and agenda for a training on the Canadian Medical Devices Conformity Assessment System (CMDCAS). The training will cover ISO 13485 quality management system audits performed by Health Canada recognized registrars, certificate requirements, and audit report content. It will also review specific CMDCAS requirements, the transition to ISO 13485:2016 and the Medical Device Single Audit Program. The objective is to help participants understand how to incorporate CMDCAS into their quality management system documentation and prepare for an audit.
This document provides guidance on best practices for conducting quality audits of active pharmaceutical ingredient suppliers. It outlines the different types of audits, including internal audits conducted by a company and external audits conducted by third parties. It describes the key steps in managing an audit, from preparation to reporting. It also provides recommendations on auditor qualifications and training. The overall goal is to help ensure effective, independent audits are performed to verify GMP compliance and drive continuous improvement.
4. MISSION
IMDRF/MC/N1FINAL:2014
“The mission of the IMDRF [International Medical Device
Regulators Forum] is to strategically accelerate international
medical device regulatory convergence to promote an efficient
and effective regulatory model for medical devices that is
responsive to emerging challenges in the sector while
protecting and maximizing public health and safety.”
5. IMDRF born February 2011 as a forum to discuss future directions in medical
device regulatory harmonization.
Voluntary group of medical device regulators from around the world who
have come together to build on the strong foundational work of the Global
Harmonization Task Force on Medical Devices (GHTF)
Accelerate international medical device regulatory harmonization and
convergence.
6. 1992 - 2012
Medical device regulatory authorities & industry
Steering committee and 5 Study Groups covering subjects:
Device Classifications; Labeling
Post Market Surveillance, Adverse Event Reporting, Reports Exchange, GMDN
Risk Management, Process Validation
Auditor Training, Regulatory Auditing Guidelines
Clinical Evaluations, Clinical Evidence
7. IMDRF Management Committee (MC) regulators:
Australia, Brazil, Canada, China, the European Union, Japan, Russia, and the USA
Observers:
APEC LSIF (Asia Pacific Economic Cooperation Life Science Innovation Forum)
WHO - World Health Organization
Affiliate Organizations:
Pan American Health Organization
Asian Harmonization Working Party
Working Groups:
Standards; MDSAP; Submissions; UDI; NCAR; Software
8. IMDRF Working group items:
National Competent Authorities Report Exchange Program
Roadmap for Implementation of Unique Device Identification system
Medical Device Single Audit Program
List of Recognized Standards
Regulated Product Submission
Software as a Medical Device
10. Recognize Auditing Organizations (AO)
Single Audit by AO would:
benefit patient health and patient access
leverage regulatory resources
minimize medical device manufacturing disruptions due to multiple regulatory
audits
provide global benefit both on short term goals and longer term goals by IMDRF
regulators
11. STATEMENT OF COOPERATION (NOV 2012)
Australia
Therapeutics Goods Administration (TGA)
Brazil
Agência Nacional de Vigilância Sanitária
(ANVISA)
Canada
Health Canada/Santé Canada
United States of America
Food and Drug Administration (FDA)
12. COOPERATION
IMDRF
Initial Recognition, Surveillance, and Re-Recognition Criteria for MDSAP
Recognized Auditing Organizations
Standardized Recognized AO Auditor Competency and Competency Maintenance
Requirements
Standardized Regulatory Authority Assessor Competency and Competency
Maintenance Requirements
Standardized Audit and Assessment Models
Auditing of a Manufacturer by an MDSAP Recognized AO
Assessment of MDSAP Recognized AO’s by participating Regulatory Authorities
13. COOPERATION
Audit duration calculations
MDSAP audit model for consistency
MDSAP report
Standardized Rating System for Manufacturer Audit Findings
Standardized Rating System for Recognized Auditing Organization
Assessment Findings
Extremely stringent impartiality requirements
15. MDSAP PILOT
Pilot started in January 2014 (for 3 years, to Dec 2016)
CB’s from participating member states can apply to AO’s
CMDCAS recognized registrars
Office audit and witnessed audit required
Conducted by regulators
September 2014 AO’s started conducting audits
Operational program slated for 2017
16. PARTICIPATING RAS As of June 2015
USA: U.S. Food and Drug Administration (FDA)
Canada: Health Canada/Santé Canada
Brazil: Agência Nacional de Vigilância Sanitária (ANVISA)
Australia: Therapeutics Goods Administration (TGA)
Japan: Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and
Medical Devices Agency (PMDA)
17. OFFICIAL OBSERVERS As of June 2015
World Health Organization (WHO) Prequalification of In Vitro Diagnostics Program
European Union
18. AUTHORIZED AO See Mid-Pilot-Report
.
BSI Group America Inc. http://www.bsigroup.com/en-US/
TÜV SÜD America Inc. http://www.tuv-sud-america.com/
SAI Global Cert. Services PTY Ltd. http://www.qmi.com
LNE G-MED http://www.gmed.fr
TÜV USA Inc. http://www.tuv-nord.com/us
Intertek Testing Services NA Inc. http://www.intertek.com
20. KIMBERLY TRAUTMAN, FDA
Associate Director, International Affairs
Office of the Center Director
Center for Devices and Radiological Health
Personal communication, 2015-10-22:
“…MDSAP is definitely going full implementation in January 2017,
so manufacturers should take advantage of the ‘learning
phase’ while they can…”
22. BENEFITS FOR MANUFACTURERS
No additional requirements for manufacturers
Single audit optimizes time and resources
Routine audits are scheduled/planned with manufacturer
Expected to improve predictability
Expected to add additional Regulatory Authorities
Some RA’s will use Pilot audit outcomes as alternatives to own inspections to process
applications for market authorization
23. PROCESS - INTEGRATED OR
STAND ALONE, MORE COMPLEX?
MDSAP can be integrated into existing audit cycle
CE requirements are not built into MDSAP audit tasks and not considered part of MDSAP
audit time, must added
Multi-site manufacturers do not get a certificate unless all relevant sites are audited under
MDSAP
No such thing as an MDSAP pre-assessment in traditional sense (all reports go to all RAs, all
NC’s count)
24. MDSAP Pilot routine audits are announced, scheduled by the Auditing Organization with the
manufacturer, with a pre-established duration.
The FDA will review MDSAP Pilot audit reports with a level of scrutiny commensurate to the
significance of audit findings, taking into account the review and follow-up performed by the
Auditing Organization.
Firms have one month to provide their full response to critical nonconformities (grade 4 and
5) to the Auditing Organization (as opposed to 15 working days following a FDA inspection).
Certification documents issued by the Auditing Organization state compliance with
applicable US regulations, which may provide a marketing advantage.
FDA will utilize other forms of Advisory Notice, where necessary instead of FDA Warning
Letters for MDSAP Audits during the Pilot. Warning Letters will only be considered when the
MDSAP audit conclusion reveals an imminent/unreasonable risk to public health.
25. Health Canada will operate the current Canadian Medical Devices Conformity
Assessment System (CMDCAS) and MDSAP in parallel during the three year pilot.
Health Canada will accept either an MDSAP certificate or a CMDCAS certificate for
the purpose of obtaining a new (or maintaining an existing) Class II, III, or IV medical
device license, pursuant to section 32 of the Canadian Medical Devices Regulations.
Upon the successful conclusion of the pilot, Health Canada intends to implement
MDSAP as the mechanism to achieve regulatory compliance for quality
management system requirements in Canada.
26. The Brazilian National Health Surveillance Agency – ANVISA will utilize the
outcomes of the program, including the reports, to constitute an important input on
ANVISA’s pre-market and post-market assessment procedures, providing, when
applicable, key information that are expected to support regulatory technical
evaluation on these issues.
Due to recent regulatory changes (RDC 15:2014), ANVISA may use MDSAP Pilot
audits in lieu of a premarket inspection by ANVISA to grant ANVISA’s GMP
Certificate to manufacturers intending to put medical devices of class III or IV on the
Brazilian market. Undergoing an MDSAP Pilot audit may accelerate ANVISA ́s GMP
certification process, which is a pre-requisite to the marketing authorization.
ANVISA can also use MDSAP Pilot audits to renew ANVISA’s GMP Certificate bi-
annually, as an alternative to an ANVISA comprehensive inspection.
27. For manufacturers intending to put medical devices of class II, III or IV on the
Japanese market, an MDSAP Pilot audit report might be utilized for a desk review
instead of a premarket inspection performed by PMDA or registered certification
bodies in Japan. An MDSAP Pilot audit report might also be utilized in this manner
for periodical post market inspections.
Undergoing an MDSAP Pilot audit may accelerate the Marketing Authorization with
fewer burdens as well as reduce some burden for a post market phase.
28. The TGA will accept MDSAP certificates as evidence of compliance with
ISO13485:2003 where the Standard has been used to demonstrate partial
compliance with the requirements of an Australian Conformity Assessment
Procedure. It is expected that Australian Sponsors may be required to submit to the
TGA, additional technical documentation to demonstrate compliance with the
requirements of the Essential Principles of Safety and Performance and the
manufacturer’s chosen Conformity Assessment Procedure.
The TGA will take into account MDSAP audit reports when deciding whether to issue
or maintain a TGA Conformity Assessment Certificate. Under some circumstances a
manufacturer may avoid routine TGA inspections.
30. RESOURCES Medical Device Single Audit
Program
http://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/
http://www.imdrf.org/workitems/wi-mdsap.asp
31. INFORMATION
Pilot Program Announcement (brief description) - link
Program Announcement (including benefits) - link
MDSAP FAQs - link
Eligible Auditing Organizations – link
MDSAP Audit Procedures & Forms - link
32. NGEYABONGA – ENKOSI KAKHULU
NGIYABONGA – I NKOMU – NDI A LIVHUHA
THANK YOU – NDIYABULELA – KE ITUMETSE
KE A LEBOGA – BAIE DANKIE – DANKE SCHÖN
33. CONTACT DETAILS
Dr. Peter Drechsler ▪ Member of the Executive Board
qtec group ▪ Humboldtstraße 30/32 ▪ 70771 Leinfelden-Echterdingen ▪ Germany
Mobile: +49 173/2462720 ▪ Phone: +49 711/469273-40
Email: peter.drechsler@qtec-group.com
Internet: www.qtec-group.com ▪ DoEasy: www.DoEasy.de
Helping you to concentrate on your core competencies: the product and the market.