MDR and QMS training for software as a medical device
Training of December 7th, 2023 - Register now
Following several succesfull editions, we are hosting a new Medical Device Regulation (MDR) and Quality Management System (QMS) training on the 7th of December 2023.
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. Many CE-marked medical devices can only enter the market after assessement of their technical file by a Notified Body, which is accredited by a national authority.
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/A11:2021 standard, together with some process requirements from the MDR specifies the requirements for a QMS. Requirements of both MDR and ISO 13485 are applicable to organizations regardless of their size.
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:A11:2021. The training is interesting for you if you are developing a medical device, either if it's a physical product or a software product. Attention will be paid to ISO 62304 and ISO 82304. Take a look at the training program 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.
|10:00-12:15||MDR and introduction to the Technical File|
|13:00-14:00||Workshop MDR implementation (classification, risk management)|
|14:00-15:00||QMS (ISO 13485)|
|15:00-16:00||ISO 62304 and ISO 82304|
|16:00-17:00||Q&A Software as medical device|