Regulatory Affairs for Medical Devices (Level 4)

Regulatory Affairs for Medical Devices (Level 4)

Time for the final path in our Regulatory Affairs series. Get to GURU status with this 4th group of courses.

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How to Create Medical Device Labels per EU MDR
How to Create Medical Device Labels per EU MDR
A session by Monir El Azzouzi, Founder and CEO at Easy Medical Device
0 hr 55 min
Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions Product Launch Advance Exclusive Webinar

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Implementing and Maintaining Changes to SaMD Under MDR
Implementing and Maintaining Changes to SaMD Under MDR
This session will cover the outline of MDR requirements for SaMD, including qualification and classification, clinical evaluation and expanded post-market activities among others.
0 hr 51 min
Product Development QMS Refinement & Regulatory Submissions Advance Exclusive Webinar

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How to Implement Risk Management into Regulatory Submissions Using Tips, Tricks, and Standards to Satisfy FDA Concerns
How to Implement Risk Management into Regulatory Submissions Using Tips, Tricks, and Standards to Satisfy FDA Concerns
A session by Mary McNamara-Cullinane. Senior Vice President of Regulatory Affairs, Alira Health.
0 hr 47 min
Product Development QMS Refinement & Regulatory Submissions Standard (Free) Webinar

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The Definitive Guide to Responding to FDA 483 and Warning Letters
The Definitive Guide to Responding to FDA 483 and Warning Letters
This guide will go into great detail regarding exactly how to respond to FDA 483 observations and warning letters.
Initial QMS Procedures QMS Refinement & Regulatory Submissions Post-Market Surveillance Advance Exclusive eBook

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How to Meet Cybersecurity Requirements of EU MDR & IVDR
How to Meet Cybersecurity Requirements of EU MDR & IVDR
EU MDR and IVDR are changing and cybersecurity requirements are no exception. Get the details in this important discussion with Justin from TUV SUD.
0 hr 54 min
Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions Advance Exclusive Webinar

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How to Predict Medical Device Recalls using Publicly Available Data
How to Predict Medical Device Recalls using Publicly Available Data
A session by Mohammed (Bilash) Hossain and John Lorenc of Reed Tech
0 hr 45 min
QMS Refinement & Regulatory Submissions Post-Market Surveillance Advance Exclusive Webinar

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Risk Management for Executives: Why Does it Matter to Me?
Risk Management for Executives: Why Does it Matter to Me?
A session by Michael Cremeans, Life Sciences Industry Practice Leader at Hylant
0 hr 44 min
Webinar

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The Who, What, and When of IVDR Enforcement
The Who, What, and When of IVDR Enforcement
A session by Joanne Lebrun, Vice President at MDC Associates Inc.
0 hr 52 min
EU MDR Post-Market Surveillance Advance Exclusive Webinar

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Risks that No One Wants to Talk About: Theoretical Risk Management vs. Life in the Real World
Risks that No One Wants to Talk About: Theoretical Risk Management vs. Life in the Real World
A session by Mike Drues Ph.D., President at Vascular Sciences
0 hr 55 min
Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions Product Launch Standard (Free) Webinar

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Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?
Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?
Check out one of our favorite podcast episodes from the Global Medical Device Podcast with Mike Drues, Ph.D.
Risk Management Ideation & Prototyping Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions Advance Exclusive Podcast

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UDI and Device Registration, Another Launch Checkbox
UDI and Device Registration, Another Launch Checkbox
A session by Gary Saner, Sr Mgr of Information Solutions at Reed Tech
0 hr 49 min
UDI QMS Refinement & Regulatory Submissions Post-Market Surveillance Webinar

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Regulatory Affairs Checkpoint Delta
Regulatory Affairs Checkpoint Delta
What an accomplishment! You spent the time, invested in your own knowledge, and now it's time to celebrate. Now hop in here and get your Guru Badge, so you can show off a little.
Advance Exclusive

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