Medical Device Regulation Masterclass

Are you developing a medical device but unsure of the requirements you need to meet? This masterclass will help you to determine your device’s risk classification and understand the necessary regulations and conformity requirements.

Who should attend?

Innovators in MedTech and digital health solutions including startup founders, academic researchers, clinicians, students and technology transfer professionals.

What will you learn?

By the end of the workshop you will be able to:

• Identify if your device / digital health solution is a medical device.
• Classify your medical device according to the Medical Device Regulation (EU) risk levels.
• Find the requirements your medical device needs to conform with.

RegMetrics

RegMetrics is a compliance software that simplifies the regulatory journey for MedTech innovators. It makes compliance easier, faster, and more cost-effective with clear, step-by-step guidance and AI tools to increase productivity.

National Institute for Health Research (NIHR)

This workshop is in partnership with the NIHR Community Healthcare MedTech and In vitro Diagnostic Co-operative (MIC), that focuses on the robust in-context evaluation and development of diagnostic devices and in vitro diagnostic tests of relevance to community healthcare.