Webinar

After-market aftermath: Methods and processes to monitor product performance

Catch the latest updates and discuss the goals of Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) in this two-part webinar series.

Part 1: The aim of Post-Market Surveillance

16 September
Watch Now On-Demand

Part 2: The importance of Post-Market Clinical Follow-Up

23 September
10:00 EDT/16:00 CEST
30 min session

 

Amplexor’s two-part webinar series in collaboration with Seyed Khorashahi will cover the key elements of Post-Market Surveillance and the purpose behind Post-Market Clinical Follow-Up.

PMS is a crucial step for manufacturers in the pharmaceutical and medical fields. Collecting data and reporting its analysis is part of quality & regulatory compliance and helps monitor the performance of commercialized products available on the market. It is of utmost importance for this to be followed by PMCF, to ensure safety and top-notch performance.

Agenda

Part 1: Post-Market Surveillance (30 min session)
Watch Now On-Demand

RCA’s Seyed Khorashahi will cover the difference between Post Market Surveillance (PMS) and vigilance, the methods and processes used to monitor product performance and the overall PMS requirements.

 

Part 2: Post-Market Clinical Follow-Up (30 min session)
23 September 10:00 EDT/16:00 CEST

Seyed will join us again to delve into why Post-Market Clinical Follow-up is a crucial step in ensuring safety and quality of new released medical grade products, by making sure the benefits outweigh the risks.

Meet the Speaker

Seyed Khorashahi

Regulatory Compliance Associates INC
Executive VP of Medical Device and CTO

Seyed Khorashahi has more than 25 years’ experience leading teams in all aspects of developing safety critical medical devices. He has held leadership positions at Covidien (Medtronic), Baxter, and Beckman Coulter, Inc. prior to joining RCA 5 years ago, and has an extensive background in medical device product development, quality systems, regulatory affairs, and mergers and acquisitions. Other core competencies include engineering and business strategy.

Seyed has significant domain expertise not only in FDA and EU standards, but also in software systems and hardware development for medical devices. He has a proven track record of efficiently deploying total product life cycle process improvements with extensive knowledge of 21 CFR 820 and ISO 13485 for management of medical devices throughout the medical device life cycle from product inception to product retirement.

REGISTRATION

After-market aftermath: Methods and processes to monitor product performance

Part 1: The aim of Post-Market Surveillance (30 min session)
Watch Now On-Demand

 

Part 2: The importance of Post-Market Clinical Follow-Up (30 min session)
23 September 10:00 EDT/16:00 CEST

Fill out the form to register