Medical Device Regulation & ISO13485 training

Datum van item

02 november

Event location: Medace facilities, Maastricht

Hele dag -

Medical Device Regulation & ISO13485 training

Medical Device Regulation & ISO13485 training

Following the very successful 1st edition of the training in May 2022 we are hosting the 2nd edition of the  Quality Management System (QMS) and Medical Device Regulation (MDR) training soon. Together with our partner Peercode we are organizing the QMS and MDR training on November 2, 2022. In order to ensure the training will be interactive limited spots are available.

About the MDR & QMS training


This full-day training workshop is a deep dive into (new) MDR and QMS requirements according to EN ISO 13485:2016. Aimed at researchers aiming to translate their innovation, starting Quality Assurance personnel and entrepreneurs. This training will help you gain in-depth knowledge on key topics, supporting your current or future medical device development

Covered topics:


Classroom training: MDR requirements for manufacturers
Including: technical documentation, clinical evaluation & Post Market Surveillance

Classroom training: ISO 13485:2016
Including: Quality Management System, Management Responsibility, Resource Management, Design & Development, Measurement, Analysis & Improvement

Hands-on workshop: MDR - Medical Device Classification

Hands-on workshop: ISO13485:2016 Risk Assessment

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