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.

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Sylvie Sion

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.

We can help you with your Medical Device Technical Documentation and clearances.

We can help you implement your Quality Management System or improve specific processes