Significant changes are underway that impact the quality and regulatory systems of medical device companies and their suppliers. ISO 13485:2016 adds new requirements to address risk management and to better align the standard with global regulatory requirements (FDA, MDD, JPAL, etc.). With the release of ISO 9001:2015, the ISO 9001 and ISO 13485 standards are no longer integrated. A new single audit MDSAP program will be in effect beginning 2017 that incorporates applicable FDA, Canadian, Brazilian, Australian and Japanese quality system requirements into the annual ISO 13485 audit cycle. The presentation will provide an overview of these changes and the steps required to incorporate these changes into existing quality management systems.
PECB Webinar: Overview of ISO 13485 - Medical DevicesPECB
The webinar covers:
• The key section of ISO 13485
• The benefits of ISO 13485
• In brief how ISO 13485 & ISO 9001 correlate
Presenter:
This webinar was presented by Raza Shah, Chief Editor and Owner of Bitehqeeq.
Link of the recorded session published on YouTube: https://youtu.be/gZlhUlqgo1g
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.
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.
PECB Webinar: Overview of ISO 13485 - Medical DevicesPECB
The webinar covers:
• The key section of ISO 13485
• The benefits of ISO 13485
• In brief how ISO 13485 & ISO 9001 correlate
Presenter:
This webinar was presented by Raza Shah, Chief Editor and Owner of Bitehqeeq.
Link of the recorded session published on YouTube: https://youtu.be/gZlhUlqgo1g
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.
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
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 – 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
This webinar goes over the major changes of the new ISO 13485:2016 standard, including the upgrade process. Program Manager Rick Burgess presented and responded to questions live on the webinar.
How to Prepare Your Organization for the Transition to ISO 13485:2016Greenlight Guru
The much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late February 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.
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.
In this presentation, you'll learn:
-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
Access full presentation here: https://www.greenlight.guru/webinar/iso-13485-2016-transition-planning
While ISO 13485 is written in black and white, the alignment between the standard's requirements and expectations is not always clear - especially in regards to SaMD (software as a medical device). This session will discuss aligning ISO 13485 with best practices for SaMD, and how we can expect the shift of the industry to impact the anchor standard of the medical device industry.
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
The primary objective of ISO 13485 certification is to standardize regulatory requirements for quality management systems. URS provide ISO 13485 certification in all India.
Computer System Validation - The Validation Master PlanWolfgang Kuchinke
Computer System Validation (CSV) is the process used to ensure and document that a computerbased system is operating according to predefined requirements. CSV is necessary when replacing paper records, like
Case Report Forms for clinical trials, with an electronic system within the highly regulated data zone that impacts public health and safety. Necessary validation documents are for example the Standard Operating Procedures (SOPs), which outline how the computer system should be used. Here, we describe in detail the System Validation Master Plan, the most important document in Computer System Validation. In contains topics, like: Validation Policy, Definition of Validation, Rules and Regulations in CSV, Legal basis, FDA 21 CFR Part 11, FDA Guidance for industry, ICH Guideline GCP, Annex 11 EU-GMP, Validation Philosophy, Organisation validation document, Audit Reports, Organisation guidelines, Organisation quality management handbook, etc.
The steps of the Validation Life Cycle are: 1. System Specification, 2. System Classification, 3. Validation Planning, 4. Establishing of the validated state, 5. Maintaining the validated state, 6. System Retirement.
[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
Computerized System Validation Business Intelligence SolutionsDigital-360
Executive Summary
Regulated pharmaceutical, biotech and medical device companies are challenged to develop manufacturing capabilities quickly and cost-effectively while at the same time safeguarding product quality and patient safety.
Validation has been an essential part of regulated industries for over 20 years, yet as the field has evolved, little has changed in the business, or manual, approach to validation.
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
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 – 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
This webinar goes over the major changes of the new ISO 13485:2016 standard, including the upgrade process. Program Manager Rick Burgess presented and responded to questions live on the webinar.
How to Prepare Your Organization for the Transition to ISO 13485:2016Greenlight Guru
The much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late February 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.
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.
In this presentation, you'll learn:
-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
Access full presentation here: https://www.greenlight.guru/webinar/iso-13485-2016-transition-planning
While ISO 13485 is written in black and white, the alignment between the standard's requirements and expectations is not always clear - especially in regards to SaMD (software as a medical device). This session will discuss aligning ISO 13485 with best practices for SaMD, and how we can expect the shift of the industry to impact the anchor standard of the medical device industry.
This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.
The primary objective of ISO 13485 certification is to standardize regulatory requirements for quality management systems. URS provide ISO 13485 certification in all India.
Computer System Validation - The Validation Master PlanWolfgang Kuchinke
Computer System Validation (CSV) is the process used to ensure and document that a computerbased system is operating according to predefined requirements. CSV is necessary when replacing paper records, like
Case Report Forms for clinical trials, with an electronic system within the highly regulated data zone that impacts public health and safety. Necessary validation documents are for example the Standard Operating Procedures (SOPs), which outline how the computer system should be used. Here, we describe in detail the System Validation Master Plan, the most important document in Computer System Validation. In contains topics, like: Validation Policy, Definition of Validation, Rules and Regulations in CSV, Legal basis, FDA 21 CFR Part 11, FDA Guidance for industry, ICH Guideline GCP, Annex 11 EU-GMP, Validation Philosophy, Organisation validation document, Audit Reports, Organisation guidelines, Organisation quality management handbook, etc.
The steps of the Validation Life Cycle are: 1. System Specification, 2. System Classification, 3. Validation Planning, 4. Establishing of the validated state, 5. Maintaining the validated state, 6. System Retirement.
[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
Computerized System Validation Business Intelligence SolutionsDigital-360
Executive Summary
Regulated pharmaceutical, biotech and medical device companies are challenged to develop manufacturing capabilities quickly and cost-effectively while at the same time safeguarding product quality and patient safety.
Validation has been an essential part of regulated industries for over 20 years, yet as the field has evolved, little has changed in the business, or manual, approach to validation.
Design controls are not an easy subject to address during and after the design of medical devices and manufacturing processes. Design controls should drive the device design process, not be an afterthought. This session focuses on treating design as a separate entity within the quality management system, user needs vs. design inputs, continuation of design controls after the transfer process, design review and more.
CAPA: Using Risk-Based Decision-Making Toward ClosureApril Bright
Implementing a risk‐based CAPA process within a QMS is a necessity in the improvement of controls aligned with product and process non-conformances, adverse events, audit findings, complaints, etc. Making decisions concerning scope and extent about these “defectives” is a modern and cost-saving approach to improvement and compliance. Every non-conformity does not force you to open a corrective action. While almost every problematic issue needs at least a correction, the biggest payback is to use corrective actions on systemically-driven problems that are repetitive and recurring.
Applying the methods of determining risk to the device’s complete life cycle will give your company a complete look at all of the device’s risks—including those relative to processes. Manufacturers should be able to justify that they have reduced the risks as far as possible as part of their risk management plan and ongoing corrective and preventive actions.
Predicting an instrument's performance over time is essential to the design phase. This session will cover reliability testing and performance deterioration, including recommendations for tests that should be performed to ensure that an instrument will function through a lifetime of use, and ways to collect measurable outputs of the instrument from initial use to the end of its lifecycle.
Design for Manufacturability Rapid Fire April Bright
Design for manufacturability (DFM) is a broadly-implemented step in today’s development process to ensure that a designed product can actually be manufactured. While the concept sounds simple, there are nuances to every supplier relationship and every new process.
Three suppliers—a contract manufacturer, additive manufacturer and plastics company—will each spend 15 minutes answering the following question: With orthopaedic customers, our greatest DFM pain point is ___ and the best strategy to change that is ___.
OEMs will learn best practices and ways to approach DFM with their supplier partners.
Strategies for Device Approval in China, India, South Korea and AustraliaApril Bright
This session will describe the orthopaedic device regulatory and registration requirements in Asia Pacific markets. Regulatory steps and strategies will be presented for each of these countries. The discussion will also cover ways to gain regulatory information about competitors already selling in these markets. Attendees will leave the session with an understanding of timelines, costs and complexity for approval.
PCBA Assembly Process Flow / PCB Assembly Manufacturing introduces the basic manufacturing process of PCBA / PCB assembly in different condition of component.It is about PCBA manufacture production.
Our PCB 101 Presentation goes through the processes involved in manufacturing a printed circuit board.
From a simple single sided board to a complex multi-layer, double sided surface mount design, our goal is to provide you a design that meets your requirements and is the most cost effective to manufacture. Our experience in IPC Class III standards, very stringent cleanliness requirements, heavy copper and production tolerances allow us to provide our customers exactly what they need for their end product.
Steps to Compliance with the European Medical Device RegulationsApril Bright
The trilogue negotiations for the European Medical Device Regulations are expected to conclude by June. Whether or not the long-awaited regulations receive another postponement, orthopaedic manufacturers cannot put off preparation or they risk their ability to sell products in Europe. Dr. Tariah will walk attendees through the greatest pain points for orthopaedic manufacturers when complying with the new regulations.
Orthopaedic Device Industry Business Models: 2020 and BeyondApril Bright
During last year’s closing keynote, Dr. Wael Barsoum underscored the importance of producing transformational, innovative products to stay competitive and maintain a strong company and a healthy supply chain. This year, Dr. Bill Tribe will shine the “innovation lens” on the value of transforming your business.
Dr. Tribe co-authored the often-cited “Medical Devices: Equipped for the Future?” study in which the orthopaedics sector is called out specifically as facing an extreme combination of forces — none of which come as a surprise or are new, but when viewed holistically (as in the image below), paint a rather obvious picture of the need for companies to respond. As you can see, orthopaedics is the only sector with 4 of 5 “hot” areas…and in this case, the odd one out (regulatory scrutiny) is still marked “critical.”
From a top-down view, the five “disruptors” listed above are acute (power shift to payors, regulatory scrutiny, unclear sources of innovation, new healthcare delivery models, need to serve lower socio-economic classes). They impact the overall orthopaedic industry intensely – but how are they impacting you? Dr. Tribe’s Keynote Address will take into account the uniqueness of the OMTEC audience: large and small OEMs, Suppliers and Service Providers.
As stated in the A.T. Kearney study, “Each company faces a different set of headwinds…while the macro-factors held true, individual experiences and prioritization depended on factors such as market geography, product life cycles and go-to-market strategies. The most effective strategies are therefore likely to be company specific.”
What will be your business model in 2020? 2025?
Will you be considering cost-structure, deployment of inventory, commercial logistics, quality and regulatory frameworks, R&D, innovation and data collection?
Dr. Tribe will break down the issues and share potential approaches to help you navigate toward a more relevant and lucrative business model – regardless of where you are in the process.
This document has been prepared to provide a summary on the changes between ISO 13485:2003 and ISO 13485:2016. The documents contains the following:
a. Benefits of the new version of the standard.
b. Few key definitions
c. Mapping between the versions as per ISO.org.
d. Summary of key changes between the versions of the standard
From May 2017, NQA is able to carry out transition audits to the revised medical device standard as a part of your next assessment.
Every organization which wishes to maintain certification to this standard must undergo a transition audit before March 2019 including resolution of any/all non-conformances raised during
the transition audit. To help get you started, the helpful annexes in the new standard have been expanded to give you more detail on where to focus your attention to understand and implement the
required changes. The work required will of course depend on your products/services and the nonapplicable cause specific to your QMS.
The ISO 13485:2016 standard governs quality management for medical devices and related services. It’s published by the International Organization for Standardization (ISO).
Get a free ISO 13485 quote from NQA today here: https://www.nqa.com/en-gb/certification/standards/iso-13485
Brief information about iso,iso22000,iso9000 which explaining with some examples, pictures, charts. Here you can gain some information about the topic.
The Future of Digital Health and Wearables in OrthopedicsrablesApril Bright
Orthopedic device companies have responded to payors’ adoption of bundled payments and FDA’s promotion of digital health tools by commercializing products that track patients beyond the O.R. Digital health tools, including wearables, provide device companies with revenue streams that respond to hospitals’ episode of care requirements and patients’ personalized medicine needs, while simultaneously creating a feedback loop for product ideas. Christopher E. Pelt, M.D., a surgeon enrolled in Zimmer Biomet’s mymobility clinical study with the Apple Watch app, offered perspective on the benefits of wearables and shares ways that the technology will impact patients, surgeons and device companies in the future.
The Future of Personalized Implants in Joint Replacement: Additive, Robotics,...April Bright
Orthopedics is primed for mass customization of implants thanks to advancements in additive, AI and robotics. Fully leveraged, the technologies can produce patient-specific implants that achieve clinical benefit, decrease cost and maintain O.R. workflow. Founder and Chief Medical Officer of Monogram Orthopaedics, Douglas Unis, M.D., shares his reimagined vision of personalized joint replacement implants and just-in-time inventory solutions.
Innovation in Orthopedics: Surgeon PerspectivesApril Bright
How can orthopedic manufacturers capitalize on the next wave of innovation? Which advancements will experience the greatest adoption in orthopedics, and why? The future of orthopedics is happening now. Progress is being made on materials that increase implant longevity, designs that improve patient outcomes and speed recovery, robotic and computer-assisted technologies that enhance accuracy, reliability and speed. This panel boasts future-minded surgeon entrepreneurs and researchers who have varied practical experience from the leading edge of tomorrow’s solutions. They shared perspective on what’s working in orthopedics, what gaps remain and how orthopedic manufacturers can develop new, relevant products that solve problems and alleviate pressures for surgeons and hospitals.
Antimicrobial Coatings: The Research and Regulatory PerspectiveApril Bright
Coatings have long been considered an avenue for infection prevention in orthopedic procedures. These coatings, some of which utilize silver, have largely not been commercialized because regulators seek greater evidence of their safety, creating a long, expensive road for device companies. Announcements in the last half of 2018 and early 2019 indicate that companies continue to push to get them on the market and that productive conversations are taking place with regulators. This session began with a history of antimicrobial coatings followed by a look at recent research and technology.
Leverage These Effective Communication Skills to Get Your Message AcrossApril Bright
Your success is highly dependent upon how well you communicate with your colleagues, your customers and your providers. Effective communication helps you reduce conflict and confusion while increasing motivation and productivity. No matter your age or title, communication is a timeless skill to practice and hone. Leveraging decades of training and managerial experience within device companies and his role as a professor, G. Bryan Cornwall provided the practical steps that you must take to become an excellent communicator.
Operations: Top Reasons for Long Lead Times and What to Do About ThemApril Bright
Long lead times remain one of the most vocalized challenges that orthopedic manufacturers face today. Customers, profits, plans and personnel are all negatively impacted by them. James Kwan has worked on the OEM and the supplier sides of orthopedics, and shared his ideas and successful experiences to help you optimally respond to lead times, reduce them and ultimately create and sustain an agile supply chain.
Computational Modeling & Simulation in Orthopedics: Tools to Comply in an Ev...April Bright
Computational Modeling & Simulation has the ability to revolutionize the orthopedic device industry by reducing and in some instances eliminating the need for benchtop testing and clinical trials. Dr. Afshari shared his experience in establishing the credibility of computational models for product design and development purposes, and highlighted was that modeling fits with the regulatory and standards framework.
Joint Replacement: The Current and Future Impact of CoatingsApril Bright
The control of surface properties to reduce wear and corrosion and improve biocompatibility is of particular interest today as device companies—and surgeons, payors and patients—seek to extend the life of knee and hip implants. In this session, device companies shared research on their joint replacement coatings and materials, covering pros, cons and the future of their technology.
Engineers: Practical Application of Project Management PrinciplesApril Bright
Predictability throughout the commercialization chain is critical to allow manufacturers to speed products to market and gain share within the growing orthopedic industry. As an engineer, your technical and regulatory expertise will be overshadowed if you cannot properly plan and execute a project. One skill every engineer must learn and hone is project management. Start with the steps shared in this session.
Regulatory and Quality Affairs: Answers to FDA and ISO Gray AreasApril Bright
Every day, people like you in companies everywhere are sidetracked from more pressing priorities by questions and scenarios that aren’t clearly explained in a regulation or standard (a.k.a. "gray areas"). This panel of regulatory and quality experts were charged with mitigating your roadblocks and getting you on your way. Our panel shared their perspective on the pressing questions received from a pre-conference attendee questionnaire, including UDI and supplier relationships.
The Future of Orthobiologics in Trauma ProceduresApril Bright
Based on his clinical research interests in utilization of Alpha-BSM bone graft substitute and OP-1 recombinant BMP in the repair of fractures, Daniel N. Segina, M.D., outlined opportunities and challenges for surgeons and device companies in biologic development. To make his case, Dr. Segina reviewed the spectrum of orthobiologics used in trauma cases today, shared perspective on what is and isn’t working and forecasted the future of regenerative medicine.
Spine Implants: Porous Coatings vs. Porous Materials vs. Additive ManufacturingApril Bright
Spine implant materials and surface characteristics are popular topics among engineers and surgeons. How do surface technologies relate to spine implants and bone integration and fusion? What are the pros and cons of various materials and surfaces? In this interactive session, members of industry and academia reviewed and presented research related to use of
• porous plasma spray coating,
• porous PEEK, and
• additive manufactured titanium in spinal devices.
How to Influence People: The Value of Employee EngagementApril Bright
Engagement is a powerful tool to drive accomplishment of individual and company objectives. Success requires a genuine interest in achieving the goals of the company as well as making connections between those goals and the personal motivations of your team. Employee engagement is lauded by many as the single most fulfilling aspect of their jobs.
Real-World Evidence: The Future of Data Generation and UsageApril Bright
As data is captured through electronic health records, registries and unique device identifiers, the generation of evidence based on this data is expected to play a crucial role in informing orthopedic manufacturers’ decisions before and after regulatory approval. While regulators, payors, hospitals and manufacturers support this shift, they acknowledge that gaps remain in its optimal execution. Priority considerations include how to generate evidence to expedite regulatory market decisions, device indication expansion, postmarket studies, postmarket surveillance and reimbursement decisions. The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), is leading the conversation with various stakeholders, including FDA and orthopedic device companies to support the sustainable generation of Real-World Evidence (RWE) using Real-World Data (RWD).
Orthopedic Coatings: Predictions for 2025April Bright
What are the next innovations in orthopedic coatings? What orthopedic market stands to benefit the most from coatings? What’s stalling coating innovation? This session brought together the device company and coating manufacturer perspective to discuss which coatings will be used in orthopedics in the next decade.
Engineers: Apply Automation to Increase Quality, Speed to MarketApril Bright
We live in the age of machine learning, artificial intelligence and other automated systems. Why, then, are we performing tedious tasks that we can streamline during the product development phase? First, there is Design Verification testing. Second, there is Design Validation testing. Some of these tests use simple pass/fail attribute data, while others use continuous data. We will focus on ways to automate the analysis of that continuous data, which can ensure more accurate and timely results.
OSMA: Orthopedic Industry's Top Regulatory Challenges and OpportunitiesApril Bright
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3. Implementing ISO 13485:2016
Introduction
Overview of changes
New QMS requirements
Implementing the requirements using PDCA
Future changes
Questions/Comments
4. Implementing ISO 13485:2016
Overview of Changes
Current State:
ISO 13485:2003 addresses general quality system
requirements for medical device manufacturers
Regulatory bodies assign criteria for meeting these
quality system requirements
Regulatory bodies establish additional requirements
specific to device safety and functionality that are not
addressed by ISO 13485:2003
5. Implementing ISO 13485:2016
Overview of Changes
Current State:
ISO 13485:2003 contains 20 clauses that require
“documented procedures” to address QMS processes
such as document control, design control, or CAPA.
ISO 13485:2003 has 10 additional clauses that require
“documented requirements “ for processes such as
maintenance or rework. These are usually documented as
work instructions.
6. Implementing ISO 13485:2016
Overview of Changes
Current State:
FDA 21CFR part 820 requires an additional 12 procedures
addressing QMS processes such as calibration, labeling or
statistical techniques.
FDA 21CFR part 820 also contains requirements for
maintaining quality records including design history files,
master device records, device history records and
complaint files.
7. Implementing ISO 13485:2016
Overview of Changes
New State:
ISO 13485:2016 now requires 26 procedures including the
original 20 procedures from ISO 13485:2003 and 6 new
procedures already required by regulatory agencies.
ISO 13485:2016 now contains requirements for
maintaining design history files, medical device records,
device history records, and complaint files.
8. Implementing ISO 13485:2016
Overview of Changes
New State:
The new procedures address management review,
competency and training, calibration, rework, complaint
handling and regulatory reporting.
There are 6 additional procedures still required by the
FDA that are not required by ISO 13485:2016: process
control, final acceptance, labeling, distribution, statistical
techniques.
10. Implementing ISO 13485:2016
QMS Documentation Requirements
4.2.3 Medical Device File
A file is required for each device type or family containing
or referencing all documents required to comply with
quality and regulatory requirements.
Typical contents are product specifications, labeling and
IFU specifications, packaging specifications, procedures
and work instructions required for product realization,
forms required as quality records.
11. Implementing ISO 13485:2016
QMS Documentation Requirements
4.2.5 Control of Records
Methods must be defined for protecting confidential
health information contained in records according to
applicable regulatory requirements.
13. Implementing ISO 13485:2016
Management Responsibility
5.4.1 Quality Objectives
Quality Objectives must also address
regulatory requirements.
Quality Objectives must be measurable – should show
performance over time using methods defined in an
Analysis of Data procedure.
Quality Objectives must be consistent with the Quality
Policy – should focus on product and regulatory
requirements and effectiveness of the quality system.
14. Implementing ISO 13485:2016
Management Responsibility
5.6 Management Review
A Management Review procedure is required
(already an FDA requirement)
Management Review inputs now include complaint
handling and regulatory reporting
(in addition to feedback)
Be sure to review quality objectives each time; review
quality policy at least annually
16. Implementing ISO 13485:2016
Resource Management
6.2 Human Resources
Organization must now document the process for
establishing competency, providing needed training, and
establishing employee awareness.
(already an FDA requirement)
Recommend a general procedure supported by individual
work instructions addressing competency, training,
and awareness.
17. Implementing ISO 13485:2016
Resource Management
6.2 Human Resources
Competency requirements are education, skills, and
experience – usually documented in job descriptions
Training needs should address new employee orientation,
safety training, procedural training, job skill training,
external certifications
Employee awareness training should help employees
understand the impact of their work upon the doctors
and patients who use the company’s products
18. Implementing ISO 13485:2016
Resource Management
6.3 Infrastructure
Requirements for facilities, equipment, and support
services must be documented
These requirements must include provisions to prevent
mixing of product and assure proper handling
PM requirements to be documented for production
equipment, environmental controls, and monitoring or
measuring equipment
19. Implementing ISO 13485:2016
Resource Management
6.4 Work Environment
Requirements for the production environment
must be documented
For sterile medical devices, the organization shall
document requirements for control of contamination
with microorganisms or particulate matter, and maintain
the required cleanliness during assembly or
packaging processes
21. Implementing ISO 13485:2016
Product Realization
7.2 Customer-Related Processes
Customer requirements now include applicable
regulatory requirements; organizations must
communicate with regulatory authorities in accordance
with applicable regulatory requirements
Customer requirements now include user training
requirements. The organization shall identify what
training is required to assure that physicians and patients
can use a device in a safe and effective manner; such
training must be made available to the device users
22. Implementing ISO 13485:2016
Product Realization
7.3 Design and Development V&V
Design verification and validation protocols/reports must
state the methods used, acceptance criteria, and
statistical rationale for sample sizes
Design validation must be performed using representative
product, such as initial production runs
Rationale for the product used must be documented in
the validation report
23. Implementing ISO 13485:2016
Product Realization
7.3 Design and Development V&V
If a device must interface or be connected to another
device during use, the device must interface or be
connected during design verification and
validation activities
In the above instance, the validation criteria must verify
the device meets the requirements for its intended use
when so connected or interfaced
24. Implementing ISO 13485:2016
Product Realization
7.3.8 Design and Development Transfer
A procedure is required for the transfer of a design
project to production
The procedure must require that design V&V activities
have been complete and production processes have been
validated prior to production transfer
25. Implementing ISO 13485:2016
Product Realization
7.3.9 Design and Development Changes
A procedure is required for the design change process
The procedure must require that design changes identify
the impact of potential changes upon the function,
performance, usability, and safety of the device, plus the
impact upon applicable regulatory requirements
26. Implementing ISO 13485:2016
Product Realization
7.3.10 Design and Development Files
A file is required for each device or device family
The file must include or reference all records that were
used to verify compliance to device requirements and to
verify any design changes
27. Implementing ISO 13485:2016
Product Realization
7.4. Purchasing – Change Notification
Purchasing information must include a written agreement
that the supplier will notify the customer prior to
implementing any changes that could impact the ability
of the product to meet requirements
When the customer becomes aware of any changes to
purchased product, the impact of the changes upon the
production process or product must be evaluated
28. Implementing ISO 13485:2016
Product Realization
7.4 Purchasing - Supplier Evaluation
Criteria must be established for supplier evaluation and
selection that is based upon supplier performance and is
proportionate to the associated risk
Supplier performance must be monitored; the results
used during supplier re-evaluation; and records must be
maintained of evaluation, selection, monitoring and re-
evaluation (supplier scorecards)
29. Implementing ISO 13485:2016
Product Realization
7.4 Purchasing
The extent of verification activities shall be based upon
supplier evaluation results and be proportionate to the
associated risk
30. Implementing ISO 13485:2016
Product Realization
7.5.4 Servicing
Servicing has been added to 8.4 Analysis of Data
Service records must be analyzed to determine if the
underlying service issue constitutes a complaint
Service records must be analyzed to determine if the
underlying service issue requires a formal
corrective action
31. Implementing ISO 13485:2016
Product Realization
7.5.6 Process Validation
Production controls must include qualification of
infrastructure (Equipment Qualification)
Processes must be validated if the resulting output
cannot OR IS NOT verified
The FDA requires validation unless the output
is 100% verified
32. Implementing ISO 13485:2016
Product Realization
7.5.6 Process Validation
Validation procedures must utilize statistical methods and
provide rationale for sample sizes
Validation of production software shall be proportionate
to the risk posed by the software
Software must be revalidated following any changes
Requirements to validate sterilization processes has been
expanded to include sterile barrier systems
33. Implementing ISO 13485:2016
Product Realization
7.5.11 Preservation of Product
Packaging and shipping containers must be designed and
constructed in a manner that will protect the product
from alteration, contamination or damage when exposed
to expected conditions or hazards
Requirements for special conditions must be documented
if packaging alone cannot preserve the product
Special conditions must be controlled and
records maintained
34. Implementing ISO 13485:2016
Product Realization
7.6 Monitoring and Measuring Equipment
Calibration activities are to be performed using
documented procedures or work instructions
Any adjustments to equipment must be documented
Software used during inspection or testing must be
validated in proportion to the risk presented
Validation requirements must be documented in a
procedure; Validation records must be maintained
36. Implementing ISO 13485:2016
Measurement, Analysis and Improvement
8.2.1 Feedback
The methods used to gather and use feedback must be
documented in a procedure or work instruction.
Feedback must be obtained from both production and
post-production activities.
Information gained from feedback should be used as an
input to the risk management process.
37. Implementing ISO 13485:2016
Measurement, Analysis and Improvement
8.2.2 Complaint Handling
A procedure is required to define requirements for the
documentation, investigation, and reporting of
complaints and handling the related product
If a complaint is not investigated, justification
must be documented
Resulting CAPA activities must be documented
38. Implementing ISO 13485:2016
Measurement, Analysis and Improvement
8.2.4 Internal Audit
Internal audit criteria must include compliance to
applicable regulatory requirements
Internal audit reports must identify the areas and
processes being audited, and conclusions reached
by the auditors
39. Implementing ISO 13485:2016
Measurement, Analysis and Improvement
8.2.6 Monitoring and Measurement of Product
Inspection records must identify the inspection
equipment used to perform measurement activities
40. Implementing ISO 13485:2016
Measurement, Analysis and Improvement
8.4 Analysis of Data
The procedure for analysis of data must define
appropriate methods for analysis, including statistical
techniques and the extent of their use.
Analysis must be performed on data from feedback,
product conformity, process trends, supplier
performance, audit results and service reports.
41. Implementing ISO 13485:2016
Measurement, Analysis and Improvement
8.5 Improvement
The organization shall identify and implement any
changes necessary to maintain effectiveness of the
quality system as well as medical device safety and
performance through the use of the quality policy, quality
objectives, audit results, post-market surveillance,
analysis of data, corrective actions, preventive actions,
and management review.
42. Implementing ISO 13485:2016
Plan, Do, Check, Act
PLAN the quality system upgrade
Perform a gap analysis to identify what new requirements
are satisfied by the current quality system.
Assign resources and timelines for creating new
procedures, work instructions, or forms.
Identify subject matter experts who can advise on the
correct interpretation of the new requirements.
43. Implementing ISO 13485:2016
Plan, Do, Check, Act
DO - Implement the new QMS requirements
Train personnel to understand the new requirements and
utilize the new documentation
Implement methods and tools for monitoring
performance of the new processes
Establish quality objectives for the new processes
Incorporate the new requirements into the
internal audit process
44. Implementing ISO 13485:2016
Plan, Do, Check, Act
CHECK – verify implementation and compliance
Utilize techniques such as line-side-review or layered
audits to assure effectiveness of the
implementation process
Verify compliance via the internal audit process
Monitor process performance using appropriate
statistical methods
45. Implementing ISO 13485:2016
Plan, Do, Check, Act
ACT – Continuous Improvement
Management monitors compliance to new requirements
during management review and takes action when
milestones or quality objectives are not being met
Corrective actions are taken when audit findings identify
the new requirements are not being met
47. Implementing ISO 13485:2016
Future State
MDSAP
Medical Device Single Audit Program addresses
requirements of 21CFR part 820, Canadian MDR,
ANVISA(Brazil), Australia, and Japan MHLW
ISO 13485:2016 audits for MDSAP participants will
include applicable QMS regulatory requirements from
participating countries