MDR/IVDR Technical File, Risk Management, QMS Workshop

SEHTA and Psephos Biomedica are running their next workshop on MDR/IVDR Technical File/Risk Management/QMS on 21 May 2020.

This one-day event will provide you with an overview and insight into:

• Quality Management Systems
• Medical Device Technical Files
• Risk Management
• Assist you in assessing your company’s current preparedness
• Provide a practical guide to the next steps that you and your company need to take to meet Technical documentation and Quality Management System requirements to gain CE Marking under the MDR/IVDR

Outcomes:

• Gain an overview of the EU MDR/IVDR Technical Documentation Requirements
• Understand the technical documentation that should be in place for each device
• Understand the key areas of compliance required
• Gain a plan of action for implementation and CE Marking under the new legislation

Register now