Don’t Have a Coronary... make the EU Regulatory Process work for you!

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As the EU Medical Device Regulation (MDR) has increased the level of scrutiny required to place a device on the EU market, startup cardiovascular device manufacturers will gain a better understanding of how to navigate the EU regulatory process to achieve timely market access.

This presentation outlines the main steps in the EU regulatory process.

Objective

Strategies for understanding the requirements and generating regulatory-compliant data throughout the certification journey in the following key areas:

The players and their roles
Medical Device Definition
Device Classification
Conformity Assessment Routes
GSPRs
Conformity Assessment Process: QMS and TD requirements
Certification Decision Making
Affixing CE Mark
Post-Market Surveillance

Agenda

Background: Regulation (EU) 2017/745
CE Mark Certification Process
Key Elements
Conclusions

Target Audience

This webinar is aimed at regulatory professionals of legal manufacturers of cardiovascular medical devices who wish to access the EU market.

Language: English

Cost: No Charge

Can't make a live session? Register now and receive a complimentary recording after the live event.

Speakers:

Ibim Tariah

Technical Business Development Director – Medical Devices, SGS

Dr. Tariah’s European regulatory affairs experience spans over 25 years and includes knowledge of combination devices incorporating biologics, drugs, and drug-biologics, along with Quality Management Systems Assessment of Medical Devices. His expertise lies in innovative non-active vascular, orthopedic, dental, and other long-term implantable devices.

Greg Jacobson

Sales Director - Medical Devices, SGS

Greg Jacobson is the Director of Sales for the medical division at SGS North America. As a senior sales and medical device professional, he contributes to strategy, recommends resourcing requirements, and improves sales processes to drive client satisfaction. Greg has many years of experience in medical device certification sales. In the last 10 years, he was responsible for managing high-risk device accounts. He has also held other sales roles both inside and outside the TIC industry.

For further information, please contact:

Dominic James
Marketing Assistant
t: +1-862-339-6737