This session provides detailed examples to demonstrate what objective evidence is important to generate and use during design control compliance but, more importantly, to develop and issue a beneficial design history file meeting the requirements in 21 CFR, Part 820.30 and ISO 13485:2016. Aside from the importance of design controls for compliance, Mr. Gagliardi demonstrates how this section of the QS regulation and the ISO standard can be facilitated as a leading edge business tool.
FDA Design Controls: What Medical Device Makers Need to KnowGreenlight Guru
FDA Design Control regulations defined in 21 CFR 820.30 have been in place for 20 years now, yet year after year they continue to be one of the top issues cited during inspections.
This does not, and should not, be the case for your medical device company.
Join us for this free, two-part webinar series presented by two of the world's leading experts on the topic to learn how to implement a design control process that will not only ensure compliance but will actually benefit your product development efforts.
(You can view both webinars here: http://www.greenlight.guru/webinar/medical-device-design-controls)
In Part 1, you'll learn about Intended Use, User Needs, Design Inputs, Design Reviews, Design History File (DHF) and Risk Management.
Specifically:
-The importance of getting your intended use right up front
-The difference between a user need and a design input that's verifiable
-What stakeholders need to be involved in the process and why
-When and how many design reviews you should hold
-Why FMEA alone is NOT risk management and how to integrate risk into the design and development process
In Part 2, you'll learn about Design Outputs, Device Master Record (DMR), Design Verification and Validation (V&V), Design Transfer and Regulatory Submissions.
Specifically:
-Why your design outputs need to be more than a drawing and their relationship to your DMR
-How usability and human factors fits into the overall product development
-Making sure you build the correct device and build it correctly with design V&V
-Common mistakes people make during design transfer to production and how to avoid them
-When you can and should make your regulatory submission
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.
FDA Design Controls: What Medical Device Makers Need to KnowGreenlight Guru
FDA Design Control regulations defined in 21 CFR 820.30 have been in place for 20 years now, yet year after year they continue to be one of the top issues cited during inspections.
This does not, and should not, be the case for your medical device company.
Join us for this free, two-part webinar series presented by two of the world's leading experts on the topic to learn how to implement a design control process that will not only ensure compliance but will actually benefit your product development efforts.
(You can view both webinars here: http://www.greenlight.guru/webinar/medical-device-design-controls)
In Part 1, you'll learn about Intended Use, User Needs, Design Inputs, Design Reviews, Design History File (DHF) and Risk Management.
Specifically:
-The importance of getting your intended use right up front
-The difference between a user need and a design input that's verifiable
-What stakeholders need to be involved in the process and why
-When and how many design reviews you should hold
-Why FMEA alone is NOT risk management and how to integrate risk into the design and development process
In Part 2, you'll learn about Design Outputs, Device Master Record (DMR), Design Verification and Validation (V&V), Design Transfer and Regulatory Submissions.
Specifically:
-Why your design outputs need to be more than a drawing and their relationship to your DMR
-How usability and human factors fits into the overall product development
-Making sure you build the correct device and build it correctly with design V&V
-Common mistakes people make during design transfer to production and how to avoid them
-When you can and should make your regulatory submission
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.
Module 01 Introduction To FdA and Quality System RegulationQACATX
An introduction to FDA and Quality System Regulations wherein participants will gain an understanding of the history of the Food and Drug Administration as well as an overview of Quality System Regulations.
Lean what 21 CFR Parts 210 and 211 are and how you an implement these regulations in your organization. For more information and tips on compliance go to http://compliance-insight.com/fda-gcp-and-gmp-training/21-cfr-210-211/
January 29, 2014 Presentation to Compliance2Go webinar, focusing on:
• Legal Framework for 510(k)’s
• Strategy Considerations – Claims & Functions
• Device Modifications
• Regulatory Mechanisms to Implement Changes
• The Review
• What To Do if FDA Says You’re NSE
• Key Lessons Learned
• Reform and Other Recent Trends at FDA
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 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.
Rules and regulations for medical device registration, forms and fees required, types of medical devices to be registered under CDSCO India.
Indian market overview
India’s medical device regulatory structure
Categories of regulated medical devices in India
No Objection Certificates
Device Registration Certificate applications
Import Licensing
India Authorized Agent selection
Costs and Timelines
Developing Regulatory Issues in India
IEC 62304 is the international standard that defines software development lifecycle requirements for medical device software. The standard was developed from the perspective that product testing alone is insufficient to ensure patient safety when software is involved. The standard requires all aspects of the software development life cycle to be scrutinized.
Prepare your medical device for market with this Action List that walks you through the complexities of IEC 62304
Premarket Notification The 510(k) ProcessMichael Swit
June 5, 2012 presentation to the Food & Drug Law Institute Introduction to Medical Device Law Conference, Palo Alto, CA, focusing on:
I.The Legal Framework For 510(k) Determinations
II.510(k) Preparation – From Planning to Content
A. Predicates: researching predicates, combination predicates, and pre-amendment predicates
B. Strategy: choosing the right claim and introducing new features
C. Assessing data requirements/pre-IDE meetings
III. Device Modifications - Choosing The Right Regulatory Mechanism
IV.The FDA Review
V.What To Do When Your Substantial Equivalence Argument Is Rejected
V. Special Topics: User Fees, Combination Products
VI. Lessons Learned: Seeing The 510(k) From The Reviewer’s Perspective
VII. Recent Trends, 510(k) Reform
VIII. Case Study
Quality Function Deployment (QFD) for Design ControlsEMMAIntl
The Food and Drug Administration (FDA) has requirements for medical device manufacturers to establish and maintain a quality system for their medical device(s). The requirement for a quality system does not necessarily introduce new concepts, but applies existing quality concepts to design, development, manufacturing, distribution and use of medical devices. Within the larger quality system requirement, a methodology to control device design and development of medical devices is required. This set of sub requirements is known as Design Controls. In this paper, the history and evolution of quality systems and their application to medical devices will be covered. A Quality tool that could be well applied to the specific area of design controls, Quality Function Deployment (QFD), is a focus of this paper.
Module 01 Introduction To FdA and Quality System RegulationQACATX
An introduction to FDA and Quality System Regulations wherein participants will gain an understanding of the history of the Food and Drug Administration as well as an overview of Quality System Regulations.
Lean what 21 CFR Parts 210 and 211 are and how you an implement these regulations in your organization. For more information and tips on compliance go to http://compliance-insight.com/fda-gcp-and-gmp-training/21-cfr-210-211/
January 29, 2014 Presentation to Compliance2Go webinar, focusing on:
• Legal Framework for 510(k)’s
• Strategy Considerations – Claims & Functions
• Device Modifications
• Regulatory Mechanisms to Implement Changes
• The Review
• What To Do if FDA Says You’re NSE
• Key Lessons Learned
• Reform and Other Recent Trends at FDA
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 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.
Rules and regulations for medical device registration, forms and fees required, types of medical devices to be registered under CDSCO India.
Indian market overview
India’s medical device regulatory structure
Categories of regulated medical devices in India
No Objection Certificates
Device Registration Certificate applications
Import Licensing
India Authorized Agent selection
Costs and Timelines
Developing Regulatory Issues in India
IEC 62304 is the international standard that defines software development lifecycle requirements for medical device software. The standard was developed from the perspective that product testing alone is insufficient to ensure patient safety when software is involved. The standard requires all aspects of the software development life cycle to be scrutinized.
Prepare your medical device for market with this Action List that walks you through the complexities of IEC 62304
Premarket Notification The 510(k) ProcessMichael Swit
June 5, 2012 presentation to the Food & Drug Law Institute Introduction to Medical Device Law Conference, Palo Alto, CA, focusing on:
I.The Legal Framework For 510(k) Determinations
II.510(k) Preparation – From Planning to Content
A. Predicates: researching predicates, combination predicates, and pre-amendment predicates
B. Strategy: choosing the right claim and introducing new features
C. Assessing data requirements/pre-IDE meetings
III. Device Modifications - Choosing The Right Regulatory Mechanism
IV.The FDA Review
V.What To Do When Your Substantial Equivalence Argument Is Rejected
V. Special Topics: User Fees, Combination Products
VI. Lessons Learned: Seeing The 510(k) From The Reviewer’s Perspective
VII. Recent Trends, 510(k) Reform
VIII. Case Study
Quality Function Deployment (QFD) for Design ControlsEMMAIntl
The Food and Drug Administration (FDA) has requirements for medical device manufacturers to establish and maintain a quality system for their medical device(s). The requirement for a quality system does not necessarily introduce new concepts, but applies existing quality concepts to design, development, manufacturing, distribution and use of medical devices. Within the larger quality system requirement, a methodology to control device design and development of medical devices is required. This set of sub requirements is known as Design Controls. In this paper, the history and evolution of quality systems and their application to medical devices will be covered. A Quality tool that could be well applied to the specific area of design controls, Quality Function Deployment (QFD), is a focus of this paper.
Optimizing Product Realization Costs Across the Value ChainCognizant
Across a range of industries, realization of cost optimization requires a holistic approach throughout the product lifecycle - requirements, design, manufacture and post-launch - in order to weed out cost overruns and ensure the highest quality process and products.
How Design Controls & Risk Management Best Practices Reduce Customer Complain...Greenlight Guru
We all know how much emphasis FDA inspectors and ISO auditors place on your customer complaint and CAPA processes. And rightfully so.
But what if there were things you could do to minimize the struggles and challenges associated with customer complaint and CAPA management?
Good news. You can decrease the number of customer complaints and reduce the volume of issued CAPAs through good product development Design Controls and Risk Management practices.
Specifically this presentation will cover:
-Influence Design Controls has on Customer Complaints
-How Customer Complaints impact your CAPA system
-Best practices for Design Controls
-Best practices for Risk Management
-Risk-based approaches to Customer Complaint and CAPA management
Watch the presentation here: https://www.greenlight.guru/webinar/design-controls-risk-management-best-practices-reduce-complaints-capas
How Design Controls & Risk Management Best Practices Reduce Customer Complain...Greenlight Guru
We all know how much emphasis FDA inspectors and ISO auditors place on your customer complaint and CAPA processes. And rightfully so.
But what if there were things you could do to minimize the struggles and challenges associated with customer complaint and CAPA management?
Good news. You can decrease the number of customer complaints and reduce the volume of issued CAPAs through good product development Design Controls and Risk Management practices.
Specifically this presentation will cover:
-Influence Design Controls has on Customer Complaints
-How Customer Complaints impact your CAPA system
-Best practices for Design Controls
-Best practices for Risk Management
-Risk-based approaches to Customer Complaint and CAPA management
Infodream Articles about Continuous Improvement, Aerospace, Quality Control a...Infodream
Articles include: 1. Lack of Training to Blame for Slow Up-take of Continuous Improvement Tools in Aerospace -- 2. SPC Vision Reduces Inspection Stages and Empowers Operators at Turbomeca UK -- 3. Real time SPC & Quality Control at Mölnlycke Health Care supports FDA’s PAT
First of a two-part article published in Pharmaceutical Technology magazine in December 2005.
Part 1 describes facility and equipment design review, validation project organization and planning, and validation master plan development.
White paper quality at the speed of digitalrajni singh
Our modern testing practices help speed up the current scope of quality assurance with help of a cognitive approach. Here is the link to download my published whitepaper on "Quality at the Speed of Digital" https://www.nagarro.com/qa-at-the-speed-of-digital #qualityassurance
CTD for client signoff and early requirements validation - 11th IEEE SW Eng...Saritha Route
This is the abstract published in the IEEE S/W Engineering Conference proceedings in the industry experience sharing section of the Intl Workshop on Combinatorial Testing. We share the experience and serendipitous findings of how CT can be used for early requirements validation.
The Business Case for Integrated Design ControlsGreenlight Guru
How leveraging these 4 approaches to FDA design controls will allow you to use them as a competitive advantage to reduce risk and get devices to market faster.
Read the full post: http://blog.greenlight.guru/business-case-design-controls
Bots for Quality: Augmenting QA's Scope in the Digital AgeCognizant
To help promote the digital journey, software quality assurance (QA) can be transformed through applying machine learning and predictive analytics to produce an insight-driven approach based on smart next-generation automation.
Second of a two-part article published in Pharmaceutical Technology magazine in January 2006.
Part 2 describes protocol development and implementation (including advice and lessons learned), preparation of turnover packages, and the evaluation and management of deviations.
The challenges facing in pharmaceutical maintenanceMANUEL PACINI
Maintenance strategies for the pharmaceutical industry.
Maintenance and service-related items are often the second-largest budget element in a laboratory after salaries and benefits
Similar to Design Controls: Building Objective Evidence and Process Architecture to Meet FDA and ISO Compliance - OMTEC 2018 (20)
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The Future of Personalized Implants in Joint Replacement: Additive, Robotics,...April Bright
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Innovation in Orthopedics: Surgeon PerspectivesApril Bright
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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.
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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
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You could be a professional graphic designer and still make mistakes. There is always the possibility of human error. On the other hand if you’re not a designer, the chances of making some common graphic design mistakes are even higher. Because you don’t know what you don’t know. That’s where this blog comes in. To make your job easier and help you create better designs, we have put together a list of common graphic design mistakes that you need to avoid.
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A tale about our culture around the use of fertilizers and pesticides visiting small farms around Ahmedabad in Matar and Shilaj.
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3. Design Controls
Begins
Concept &
Feasibility
Risk Analysis
Begins
Manufacturing
Design
Review
Design
Review
Design
Review
Require Pilot
Mfring.
Phase
Product
Release
User Needs Verification
Design Validation
Design
Changes
Begin
DHF Begins
Design History File
Marketplace
Post Production
Product
History
Outputs OutputsOutputs
Design
Plan
QRB
Design Processes
Transfer
Inputs
In Continuum
DMR & the
Medical
Device File
10. Design Controls
Begins
Concept &
Feasibility
Risk Analysis
Begins
Manufacturing
Design
Review
Design
Review
Design
Review
Require Pilot
Mfring.
Phase
Product
Release
User Needs Verification
Design Validation
Design
Changes
Begin
DHF Begins
Design History File
Marketplace
Post Production
Product
History
Outputs OutputsOutputs
Design
Plan
QRB
Design Processes
Transfer
Inputs
In Continuum
DMR & the
Medical
Device File
27. Design Controls
Begins
Concept &
Feasibility
Risk Analysis
Begins
Manufacturing
Design
Review
Design
Review
Design
Review
Require Pilot
Mfring.
Phase
Product
Release
User Needs Verification
Design Validation
Design
Changes
Begin
DHF Begins
Design History File
Marketplace
Post Production
Product
History
Outputs OutputsOutputs
Design
Plan
QRB
Design Processes
Transfer
Inputs
In Continuum
DMR & the
Medical
Device File
42. Design Controls
Begins
Concept &
Feasibility
Risk Analysis
Begins
Manufacturing
Design
Review
Design
Review
Design
Review
Require Pilot
Mfring.
Phase
Product
Release
User Needs Verification
Design Validation
Design
Changes
Begin
DHF Begins
Design History File
Marketplace
Post Production
Product
History
Outputs OutputsOutputs
Design
Plan
QRB
Design Processes
Transfer
Inputs
In Continuum
DMR & the
Medical
Device File
43. When is Design Input Established?
Design Inputs Approved
(User Needs) (Design Input)
Development
Begins
User
Needs
End
Research Development
71. Example: Simple Design Matrix
Patient Monitor
Discuss Design Validation
User Need Design Input Design Output Design Verification
Portable
Instrument
• Dimensions no greater than
18.0” x 13.0” x 7.5”
• Weight = less than 11.5 lbs
Housing Drawing #765-003
Monitor Specification #763-124
Measure the Housing
Weigh the parts and weigh the
entire instrument
• Can be carried with one
gloved or bare hand
Handle Assembly Drawing #59-02 Measure the handle size
Used in a USA MD’s
Office
Operates on US Standard
Electrical Voltage
Electrical Plug Specification #77
Transformer Specification # V89 Measure the Voltage output
110-volt AC (110V) or 220-volt
AC (220V)
79. Design Controls
Begins
Concept &
Feasibility
Risk Analysis
Begins
Manufacturing
Design
Review
Design
Review
Design
Review
Require Pilot
Mfring.
Phase
Product
Release
User Needs Verification
Design Validation
Design
Changes
Begin
DHF Begins
Design History File
Marketplace
Post Production
Product
History
Outputs OutputsOutputs
Design
Plan
QRB
Design Processes
Transfer
Inputs
In Continuum
DMR & the
Medical
Device File
124. Design Controls
Begins
Concept &
Feasibility
Risk Analysis
Begins
Manufacturing
Design
Review
Design
Review
Design
Review
Require Pilot
Mfring.
Phase
Product
Release
User Needs Verification
Design Validation
Design
Changes
Begin
DHF Begins
Design History File
Marketplace
Post Production
Product
History
Outputs OutputsOutputs
Design
Plan
QRB
Design Processes
Transfer
Inputs
In Continuum
DMR & the
Medical
Device File
142. Design Controls
Begins
Concept &
Feasibility
Risk Analysis
Begins
Manufacturing
Design
Review
Design
Review
Design
Review
Require Pilot
Mfring.
Phase
Product
Release
User Needs Verification
Design Validation
Design
Changes
Begin
DHF Begins
Design History File
Marketplace
Post Production
Product
History
Outputs OutputsOutputs
Design
Plan
QRB
Design Processes
Transfer
Inputs
In Continuum
DMR & the
Medical
Device File