About the One Day Training Medical Device Software
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.
Subjects of the One Day Training Medical Device Software
The following topics will be discussed during the Medical Device Software training:
- When does the software need to comply with 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
Results of the One Day Training Medical Device Software
During the Medical Device Software training you will learn:
- 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
The course One Day Training Medical Device Software is suited for Medical Device software engineers, project managers, product managers, testers, quality and regulatory engineers. Management of medical device software manufacturers and suppliers are able to take the course. Professionals with a master or bachelor level, or equivalent knowledge gained through experience.
The One Day Training Medical Device Software training consists of 1 day from 9 am to 4 pm.
Date, locations & schedule
Location: Eindhoven – High Tech Campus 29
Location: Enschede – Hengelosestraat 500 (Building The Gallery)
The investment for the One Day Training is €795 per participant, excluding VAT. Included is one interactive training day and paper course material, which will be sent to you in advance.
Experienced Project Manager with a demonstrated history of working in the medical device industry. Project management professional and Regulatory specialist skilled in managing the development of (software) products with a strong affinity for Quality assurance and Regulatory affairs.
Participants receive a certificate of participation.
Method of teaching
The One Day Training Medical Device Software training is offered as an in-class course, but any other form is open for negotiation. We are able to offer offline, online and hybrid courses. In the case of one or more non-Dutch speaking participants, the course is given in English
Maximum group size: 10
After the training, holland-innovative optionally offers on-the-job coaching to further improve and implement the medical device development process and practices in your company. This course can also be given within your company, tailored to your specific needs. The course can be extended with topics, like:
• CE certification of medical device
• Project Management