Quality Management System ISO 13485

ISO 13485 as a QMS

Quality management system is mandatory for medical device manufacturers and some other operators in EU and most other parts of the world. ISO 13485 is well recognised QMS standard and creates a solid foundation for quality management system. In EU it is even harmonised for MDR and IVDR, thus intended by EU to be used with medical devices. ISO 13485 must always be complemented with applicable regulatory requirements.

How can we help?

• Planning the QMS together with the manufacturer according to applicable standards and regulations
• Helping the manufacturer to identify all processes needed for their QMS
• Preparing the Quality Manual, QMS process descriptions, templates, databases, and other documentation needed together with the manufacturer
• Helping the manufacturer to choose and implement electronic QMS when needed
• Helping the manufacturer to maintain and continually improve their QMS
• Helping the manufacturer with daily QMS activities including nonconformances, feedback, complaints, internal and supplier audits, vigilance, and many others
• Offering customised and open training for medical device QMS