Medical Device Regulation & ISO13485 training

Register now for the training of November 2, 2022

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 Medace 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. Click here to register.

About the MDR & ISO 13485:2016

Medical device companies that intend to sell their products in the European market place must comply with the MDR legislation (EU 2017/745). This set of regulations came into effect as of May 2021 and replaced the Medical Device Directive (MDD). This change has introduced reclassification, new requirements and additional clinical & post-market activities for manufacturers of medical devices.

The Medical Device Regulation also requires the manufacturer of medical devices and related services to establish an appropriate QMS for the design, manufacture, and use of the devices. The ISO 13485:2016 standard specifies the requirements for a QMS where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and relevant regulatory requirements. Requirements of ISO 13485:2016 are applicable to organizations regardless of their size.

MDR and quality management system training at Medace

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. Take a look at the detailed agenda below.

Costs of participation are 449 Euro excl. VAT and includes full-day training with multiple key speakers, lunch and drinks. At the end of the MDR & QMS training there is ample opportunity to network with fellow entrepreneurs and scientists.  Contact us in case of multiple registrations.

Register today and secure your spot!


Agenda

09:00-09:30 Introduction
09:30-11:15 MDR: General, Requirements for Manufacturers, Technical Documentation, Clinical Evaluation & Post Market Surveillance
11:15-11:30 Break
11:30-12:30 QMS: introduction, Management Responsibility, Resource Management, Design & Development, Measure, analyse & improvement
12:30-13:30 Lunch
13:30-14:30 MDR case: Medical Device Classification
14:30-14:45 Break
14:45-16:30 QMS case: Risk Assessment
16:30-17:00 Training wrap-up
17:00-18:00 Closing drinks