After this training, you will be able to:
- Explain the key CE marking aspects from the Medical Device Regulation (MDR)
- Understand software life cycle processes according to IEC 62304
- Apply safety risk management principles according to ISO 14971
- Understand usability engineering according to IEC 62366-1
- Recognise how Agile practices can be applied in medical device software development
Compliance of medical grade software with EU regulations is often underestimated. You need to classify your software, determine applicable requirements and standards, plan your software development, perform risk assessments, test your software, perform usability tests and provide documented evidence. This one-day training gives you an overview of the applicable regulations and standards for medical grade software and provides practical knowledge on how to apply the requirements of the MDR (Medical Device Regulation) and the relevant standards in your software development process.
This training is suited for medical grade software engineers, project managers, product owners, quality engineers, regulatory engineers and management of medical grade software manufacturers and suppliers. The training is intended for professionals with bachelor or master level knowledge, or equivalent knowledge gained through experience.
Nico van Oene, QA/RA Consultant. Nico is a QA/RA consultant with several years of experience in software development for medical devices. He has over 30 years of experience in software engineering in various roles, including software engineer, project manager, Scrum Master, QA officer and process improvement consultant. Nico supports software projects on QA/RA aspects and provides consultancy to medical companies on software development-related topics.
