Learn about your obligations as medical device manufacturer, assess what in your quality management needs to be updated, and ensure that your devices and their documentation are in compliance with the regulation's requirements.
Founder of SYMA Consulting.
Manages consulting projects and consultants in different standards.
Certified auditor for Medical Devices, Standards and Regulations (MDR, MDSAP, ISO13485) for Notified Bodies and Auditing Organizations.
Senior Consultant, Auditor and Instructor.