Eva Rejhons
10 October 2025
Overview of Regulatory Affairs for Medical Devices
10-hour
Medical Device Classifications, Conformity Assessment Routes, General Safety and Performance Requirements, Technical Documentation and other regulatory aspects of the QMS, Clinical Evaluation, Post Market Surveillance (PMS), PMCF & Vigilance, Risk Assessment and Management.
Anne Jury

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Eva Rejhons

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Credential Verification

Issue date: October 10, 2025

ID: 34e40204-2a98-4711-8a17-dd0420d3ca71

Educo Life Sciences is a learning and development specialist that provides technical training solutions to the pharmaceutical, biotechnology, cell and gene, and medical device industries. ,

Type

Course

Level

Professional

Format

Online

Duration

10 hours

Price

Paid

Description

The holder of this certificate has attended the course "Overview of EU Regulatory Affairs for Medical Devices".

This course will provide you with a comprehensive understanding of the regulatory requirements from device classification and conformity assessment routes to clinical requirements and post market factors. You will develop a deep knowledge of the MDR and its impact throughout device development and distribution. The course will also fine tune your regulatory soft skills so you can continuously maintain your regulatory knowledge and perform with confidence.

Earning Criteria

Participation

Attended the live online course held by Educo Life Sciences

Watching

Or watched the recorded materials for the course held by Educo.