TRIGA Consulting GmbH & Co. KG

Compliance

• Prepare and update technical documentation for medical devices in accordance with MDR 2017/745
• Ensure compliance with applicable regulatory requirements
• Develop test plans, organize testing activities, and define test parameters and equipment
• Create standardized test reports to demonstrate compliance with relevant standards
• Serve as the primary contact for notified bodies during technical documentation reviews and for regulatory inquiries from development and production teams
• Define regulatory strategies for the approval of medical devices

Regulatory Affairs Manager – Medical Device