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What happens when you bring three regulatory experts together on the same podcast? They talk all things market entry, from comparing the US to Europe and MDR, explaining how QMSR will impact submissions, and just how easy it is (or isn't) to bring AI-driven devices to market. Check it out! Keywords: medical devices, FDA 510 k process, medical device regulatory affairs, FDA 501k, medical device ...

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(...

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...

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...

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...

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...

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...

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...

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...

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...

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?

Design Controls and Risk Management I - What are Design Controls?

Top Regulatory Mistakes: Too Little Too Late

QMSR Masterclass - Everything You Need to Know

What are the Benefits of 3rd Party FDA Reviewers?

Global Pathways Summit: FDA Submission Strategies

Top Regulatory Mistakes: Being Too Much In Love with Your Own Science

eSTAR 5.0 - Are You Ready?

Never Have I Ever - One Random Study Does Not an Intended Use Make

Top Regulatory Mistakes: Startups, Quality and Contract Manufacturers

Top Regulatory Mistakes: Making the Wrong Assumptions about Your 510k

eSTAR: What You Need to Know

Medical Devices 101: An Entry Level Overview of the FDA

Breaking Down the "New" Biocompatibility Guidance on ISO 10993

Why You Need a Regulatory Strategy: Madman vs Medman

Breaking Down FDA's Insane Draft Guidance on Choosing a Predicate

Make Quality Make Sense: Purchasing Controls

Top Regulatory Red Flags to Avoid