ISO 13485 defines the specific requirements for medical products beyond the ‘traditional’ ISO 9001.
Rhein S.Q.M. service description:
Comprehensive certification service by Rhein S.Q.M. incl. support for risk management in compliance with ISO 14971, documentation, implementation of internal audits and clearing with accredited certification authorities. We guarantee the smooth and successful implementation of all your certification projects. Depending on customer requirements, we also offer continuous support for your business-specific QM system after certification.
Benefits for our clients:
The highest requirements for medical product manufacture in terms of documentation, verification, validation and traceability are met and surpassed. Very attractive due to the comparatively high margins in the market segment for medical products. Optimised security due to focused and perfectly adapted fulfilment of standard requirements.
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