Regulatory Affairs for Medical Devices (Level 3)

Regulatory Affairs for Medical Devices (Level 3)

The third level of this RA learning path is ready for you! Are you ready to take your knowledge to the next level?

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Documenting Risk Management to Meet Requirements of ISO 14971:2019
Documenting Risk Management to Meet Requirements of ISO 14971:2019
A session by Edwin Bills, Consultant
0 hr 50 min
ISO 14971 Regulatory Management Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions Product Launch Post-Market Surveillance Standard (Free) Webinar

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Economic Operators: Implementation Challenges and Opportunities
Economic Operators: Implementation Challenges and Opportunities
Learn about the changing responsibilities for Economic Operators in the medical device industry and how to turn compliance into opportunities for your business.
0 hr 53 min
Initial QMS Procedures QMS Refinement & Regulatory Submissions Product Launch Advance Exclusive Webinar

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Effective Post-market Surveillance in the EU under MDR
Effective Post-market Surveillance in the EU under MDR
Check out this engaging discussion if you are looking to know more about how EUMDR is changing post-market surveillance.
0 hr 51 min
QMS Refinement & Regulatory Submissions Product Launch Post-Market Surveillance Advance Exclusive Webinar

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Essentials for Clinical Evaluation of Medical Devices
Essentials for Clinical Evaluation of Medical Devices
The Globiox team will discuss how the latest updates to EU MDR & IVDR may impact your approach to post-market clinical follow-ups, how to optimally demonstrate equivalency in your report, and how to establish a continuous follow-up process for post-market.
0 hr 53 min
Initial QMS Procedures QMS Refinement & Regulatory Submissions Clinical Standard (Free) Webinar

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Risk Management According to EU MDR or ISO 14971?
Risk Management According to EU MDR or ISO 14971?
A session by Peter Sebelius, Founder at Medical Device HQ
0 hr 53 min
ISO 14971 Regulatory Management Ideation & Prototyping Product Development QMS Refinement & Regulatory Submissions Product Launch Standard (Free)

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Applying a Risk-Based Approach to Biological Evaluation of Medical Devices Based on the Framework of ISO 10993-1:2018
Applying a Risk-Based Approach to Biological Evaluation of Medical Devices Based on the Framework of ISO 10993-1:2018
What does ISO 10993 require and what are some best practices when applying risk to these evaluations? Learn more from our partner Nelson Labs in this discussion.
0 hr 48 min
Product Development QMS Refinement & Regulatory Submissions Advance Exclusive Webinar

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MDR with Brexit: How the Combination is Impacting the European Medical Device Industry
MDR with Brexit: How the Combination is Impacting the European Medical Device Industry
In this presentation we will be discussing the status of the medical device industry regarding MDR and Brexit, and what are others doing to get ready.
0 hr 53 min
Webinar

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Prepare Now for the EUDAMED UDI/Registration Module
Prepare Now for the EUDAMED UDI/Registration Module
UDI data requirement experts Gary Saner and John Lorenc of Reed Tech will discuss best practices for UDI preparations for the upcoming EUDAMED UDI/Registration Module.
0 hr 59 min
Initial QMS Procedures QMS Refinement & Regulatory Submissions Product Launch Webinar

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Protecting your Data from Risk: To, From, and In the Cloud
Protecting your Data from Risk: To, From, and In the Cloud
A session by Chris DuPont, CEO at Galen Data
0 hr 45 min
Ideation & Prototyping Product Development QMS Refinement & Regulatory Submissions Product Launch Post-Market Surveillance Advance Exclusive Webinar

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The Intersection of Medical Device Usability and Risk Management
The Intersection of Medical Device Usability and Risk Management
Mike Drues joins the podcast again to talk some more about Risk Management
Risk Management ISO 14971 Product Development QMS Refinement & Regulatory Submissions Standard (Free) Podcast

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The New MDR: Is it Really New and Do We Really Need It?
The New MDR: Is it Really New and Do We Really Need It?
A session by Mike Drues Ph.D., President at Vascular Sciences
1 hr 5 min
Initial QMS Procedures QMS Refinement & Regulatory Submissions Product Launch Webinar

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The Road to 2024: Regulatory Risks Related to Changed Post-Market Surveillance Requirements and Notified Body Certification
The Road to 2024: Regulatory Risks Related to Changed Post-Market Surveillance Requirements and Notified Body Certification
The presentation examines the post-Date of Application period, including - The MDR has more detailed formal PMS requirements.
0 hr 51 min
Regulatory Management QMS Refinement & Regulatory Submissions Standard (Free) Webinar

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Regulatory Affairs Checkpoint Charlie
Regulatory Affairs Checkpoint Charlie
You've gone from a Specialist to an Authority and you aren't done yet! Complete the courses in Level 3 and visit this checkpoint to get your Expert badge!
Advance Exclusive

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