Quality System EN ISO 13485 | MDV-Solve
Quality Management System
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Key services:
- QMS implementation and maintenance
- Internal audits
- SOP development and review
- Management review support
- Training on ISO 13485 requirements
Related Services
Post-Market Surveillance and Vigilance
Establishment and implementation of PMS to review experience gained from devices in the post-production phase.
+ Learn MoreProcess Validation Including Software
Implementation of process validation system including IQ, OQ, and PQ qualifications.
+ Learn MoreThe New EU IVD Regulation (IVDR)
The In Vitro Diagnostic Regulation stipulates all requirements IVD manufacturers must comply with.
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