Compliance of your medical device software to EU regulations is certainly not something you would do on a Friday afternoon, but is often underestimated, especially now the regulations have been updated to the MDR. You need amongst others to classify your software, determine the applicable requirements and standards, plan your software development, perform risk assessments, test your software, perform usability tests and provide documented evidence.
This newly developed one day training will give you an overview of the applicable regulation and standards for Medical Device Software and will provide you with practical knowledge on how to apply the requirements of the MDR (Medical Devices Regulation) and the applicable standards in your software development process.
A selection of subjects that will be addressed
- When does software need to comply to the MDR?
- Classification of Medical Device Software
- Summary on CE certification and when do you need a Notified Body?
- Determine applicable Safety and Performance Requirements and Standards
- Quality Management System based on ISO 13485 for a software company
- Software life cycle processes according to IEC 62304
- Safety Risk Management according to ISO 14971
- Usability Engineering according to IEC 62366-1
- Agile practices
Target group for this course
- The training “Medical Device Software – Application of MDR requirements” is suited for:
– Medical Device software engineers, project managers, product managers, testers, quality and regulatory engineers
– Management of medical device software manufacturers and suppliers.
- The course is suited for professionals with a master or bachelor level, or equivalent knowledge gained through experience.
- Knowledge of Software development, CE certification, MDR or standards is not required.
Location and investment:
Enschede: The Gallery – Hengelosestraat 500
The investment for the One Day Training is €795 per participant, excluding VAT. Included is one inter-active training day and paper course material, which will be sent to you in advance.
Course duration and number of participants:
1 day from 9 a.m. to 4 p.m. Maximum group size: 10. Our training courses are given in Dutch as standard. In the case of one or more non-Dutch speaking participants, the training is given in English.
After completing the training, participants receive proof of participation
Jolande Koobs – Sr. Project Manager Medical Devices
Do you have a question about one of our courses? Contact us for free advice about the possibilities.
T: +31 (0)40 851 4610