Quality Management System (QMS)

Eurofins Medical Device Consulting provides expertise in the development, implementation, updating, and maintenance of a quality management systems (QMS) - adhering to ISO 13485 and 21 CFR part 820. Our guidance addresses concerns across the medical device product lifecycle, from initial conception to production and post-production - covering aspects such as storage, distribution, installation, and servicing to maintain robust QMS processes.

As part of designing your QMS, our team develops and integrates manufacturing excellence with regulatory compliance - addressing compliance with conformity assessment procedures and procedures for management of modifications to subject devices.

We also assist with preparation of and updates to Quality Management Systems in compliance with ISO 13485.

Our primary services include:

• Development of QMS policies and procedures
• Preparation and implementation of Quality Manuals
• Implementation of Standard Operating Procedures (SOP) and quality processes
• Internal Audits and Supplier Qualification