leanRAQA
leanRAQA
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Masterclass: CE Certification vs FDA Strategy
MDR and FDA are like fraternal twins - similar but different.
The governance structure is different, the fee schedule is different, even the ways of communicating are different, all of which adds to the challenge of dealing with the complexities and idiosyncrasies of MDR.
Keywords: medical devices, FDA 510 k process, medical device regulatory affairs, FDA 501 medical device regulation, FDA 510(k), medical device classification, FDA 510k clearance, regulatory affairs, FDA 510k approvals, regulatory affairs medical devices, FDA pre submission, regulatory compliance, FDA submission, FDA 510k submission guidance
Переглядів: 49

Відео

QMSR and MDSAP - The Real Deal
Переглядів 5214 днів тому
Are you clear on how QSMR, ISO 13485 and MDSAP overlap? Do you understand how they're different? Do you know what you need to do if complying with all three? In this presentation from the Medtech Canada MedTech Conference, I walk you through the similarities and the differences so you can lay out the best compliance strategy for your device. Keywords: medical devices, FDA 510 k process, medical...
Master Class - FDA Pre-Submissions
Переглядів 188Місяць тому
The FDA pre-submission is a very powerful tool to help medical device manufacturers increase their chances of being granted market clearance. But too many opt not to take advantage of the opportunity, or don't know how to make the most of it. This Master Class will teach you everything you need to know about the FDA pre-submission process. Keywords: medical devices, FDA 510 k process, medical d...
Biocompatibility and Fraudulent Data in the Age of AI
Переглядів 182Місяць тому
With the advent of AI, there has been a spike in the amount of fraudulent data submitted to the FDA. Some unethical testing labs are simply mining 510(k) data from the 1990s and passing it off as fresh data - leaving manufacturers scrambling. In this conversation with Mike McGrew and Sandi Schaible from Wuxi, we discuss what manufacturers can do to ensure that they don't get caught up in this s...
Design Controls and Risk Management VI - Risk Management Tools
Переглядів 154Місяць тому
Sixth in a series of clips from our most popular video Keywords: Medical devices, regulatory affairs, regulatory compliance, medical device risk management, quality management, quality management system, risk management, risk management plan, risk management strategy, risk management framework, medical device regulatory affairs, medical device regulation, risk analysis and management, risk asse...
Design Controls and Risk Management V - Risk Management File, Hazard Identification and Terminology
Переглядів 103Місяць тому
Fifth in a series of video clips derived from our most-viewed video. Keywords: Medical devices, regulatory affairs, regulatory compliance, medical device risk management, quality management, quality management system, risk management, risk management plan, risk management strategy, risk management framework, medical device regulatory affairs, medical device regulation, risk analysis and managem...
What QMSR Means for YOU
Переглядів 204Місяць тому
QMSR and QSR sound practically the same, but that one little M makes a world of difference. But what's even more interesting is how the QMSR intertwines with ISO 13485. This presentation was recorded at the 10x Medical Device Conference in 2024. Keywords: medical devices, FDA 510 k process, medical device regulatory affairs, FDA 501k, medical device regulation, FDA 510(k), FDA 510k clearance, r...
FDA Regulatory Pathways and Programs
Переглядів 2412 місяці тому
Pour yourself a drink and get comfy, because this presentation covers just about everything you need to know about FDA submission strategies: The Five Steps to Market Crash Course in FDA Submissions 513(g) Request for Information Breakthrough Device Program Safety Technologies Program (STeP) eSTAR Webinar originally presented to the Consortium for Technology and Innovation in Pediatrics: www.ct...
Design Controls and Risk Management IV - Design History File and Design Change
Переглядів 402 місяці тому
Fourth in a series of clips from our most popular video. Keywords: Medical devices, regulatory affairs, regulatory compliance, medical device risk management, quality management, quality management system, risk management, risk management plan, risk management strategy, risk management framework, medical device regulatory affairs, medical device regulation, risk analysis and management, risk as...
Design Controls and Risk Management III - Design Review and Transfer
Переглядів 442 місяці тому
Third in a series of clips derived from our most popular video. Keywords: Medical devices, regulatory affairs, regulatory compliance, medical device risk management, quality management, quality management system, risk management, risk management plan, risk management strategy, risk management framework, medical device regulatory affairs, medical device regulation, risk analysis and management, ...
Design Controls and Risk Management II - What is the Design Plan?
Переглядів 1002 місяці тому
What are the phases of design and how do they relate to design controls? Michelle and Ti walk you through design inputs, design outputs, and the traceability matrix you need to keep track of it all. Second in a series of clips derived from our most popular video. Keywords: Medical devices, regulatory affairs, regulatory compliance, medical device risk management, quality management, quality man...
Design Controls and Risk Management I - What are Design Controls?
Переглядів 962 місяці тому
𝘔𝘪𝘤𝘩𝘦𝘭𝘭𝘦, 𝘸𝘩𝘢𝘵 𝘦𝘹𝘢𝘤𝘵𝘭𝘺 𝘈𝘙𝘌 𝘥𝘦𝘴𝘪𝘨𝘯 𝘤𝘰𝘯𝘵𝘳𝘰𝘭𝘴? Simply put - design controls are a set of practices and procedures that control the design process to ensure that your device meets users needs, aligns with your intended use, and meet the specified requirements. Tianna Benson walks you through the rest - enjoy! First in a series of clips derived from our most popular video. Keywords: Medical devices,...
Top Regulatory Mistakes: Too Little Too Late
Переглядів 594 місяці тому
Top Regulatory Mistakes: Too Little Too Late
QMSR Masterclass - Everything You Need to Know
Переглядів 6264 місяці тому
QMSR Masterclass - Everything You Need to Know
What are the Benefits of 3rd Party FDA Reviewers?
Переглядів 274 місяці тому
What are the Benefits of 3rd Party FDA Reviewers?
Global Pathways Summit: FDA Submission Strategies
Переглядів 2194 місяці тому
Global Pathways Summit: FDA Submission Strategies
Top Regulatory Mistakes: Being Too Much In Love with Your Own Science
Переглядів 425 місяців тому
Top Regulatory Mistakes: Being Too Much In Love with Your Own Science
eSTAR 5.0 - Are You Ready?
Переглядів 4145 місяців тому
eSTAR 5.0 - Are You Ready?
Never Have I Ever - One Random Study Does Not an Intended Use Make
Переглядів 165 місяців тому
Never Have I Ever - One Random Study Does Not an Intended Use Make
Top Regulatory Mistakes: Startups, Quality and Contract Manufacturers
Переглядів 1256 місяців тому
Top Regulatory Mistakes: Startups, Quality and Contract Manufacturers
Top Regulatory Mistakes: Making the Wrong Assumptions about Your 510k
Переглядів 2096 місяців тому
Top Regulatory Mistakes: Making the Wrong Assumptions about Your 510k
eSTAR: What You Need to Know
Переглядів 3686 місяців тому
eSTAR: What You Need to Know
Medical Devices 101: An Entry Level Overview of the FDA
Переглядів 1,8 тис.7 місяців тому
Medical Devices 101: An Entry Level Overview of the FDA
Breaking Down the "New" Biocompatibility Guidance on ISO 10993
Переглядів 1288 місяців тому
Breaking Down the "New" Biocompatibility Guidance on ISO 10993
Why You Need a Regulatory Strategy: Madman vs Medman
Переглядів 999 місяців тому
Why You Need a Regulatory Strategy: Madman vs Medman
Breaking Down FDA's Insane Draft Guidance on Choosing a Predicate
Переглядів 7710 місяців тому
Breaking Down FDA's Insane Draft Guidance on Choosing a Predicate
Make Quality Make Sense: Purchasing Controls
Переглядів 6310 місяців тому
Make Quality Make Sense: Purchasing Controls
Top Regulatory Red Flags to Avoid
Переглядів 560Рік тому
Top Regulatory Red Flags to Avoid
Make Quality Make Sense - Management's Role in QMS
Переглядів 121Рік тому
Make Quality Make Sense - Management's Role in QMS
Make Quality Make Sense: How NOT to do Document Control
Переглядів 125Рік тому
Make Quality Make Sense: How NOT to do Document Control