Quality System Consulting and Audits
anteris medical has a vast experience in auditing and setting up Quality Management Systems for Medical Device and Combination Product manufacturers. We offer an end to end support from the strategic planning of a QMS in order to fit into an already existing organization and the products in scope through the implementation of lean and tailored processes to meet all requirements of the respective QMS until successful certification. For example for a Medical Device organization with class IIa devices we took over the implementation of processes according to ISO 13485:2016 and all direct interactions with the respective certification Body (Notified Body in this case) to align and plan all steps of a certification process comprising the obligatory stages of a certification audit. Also, anteris medical organized the audit setup including front and back office and was the single point of contact for the auditors.
anteris medical was proud that the customer held the ISO 13485:2016 certificate in hands just a few weeks later.
- ISO 13485:2016
- 21 CFR 820
- Supplier management
- Design Control
- Small companies with few processes and documentation often lack the required experience what authorities and Notified Bodies.
- Especially for Combination Product manufacturers with existing gmp system it needs to be strategically decided how the QMS shall be implemented into the existing process landscape.
- Implementation of ISO 13485:2016 or 21 CFR 820 compliant and lean processes for SMEs and large enterprises
- anteris medical takes over the quality management representative role if desired by the customer
- Selection of a suitable Notified Body if needed
- Organization and execution of certification audits