Through our participation in technical committees, working groups and trade organizations, and our extensive experience from the medical device industry, we understand the challenges in dealing with the EU’s regulatory environment. 

QARA Consulting offers a complete set of training modules for regulatory and clinical processes in the medical device industry. 

• Software validation
• Cyber security
• GAP analysis workshops for MDR
• Technical file writing
• Cleanroom introduction course: Cleanroom principles, behavior in cleanroom
• Courses in cGMP: contamination control in cleanrooms (aseptic and non-aseptic operations)
• Training in clinical evaluation according to MEDDEV 2.7/1
• Customized training