The international requirements for quality management in the context of CE-marking are outlined in the standard EN ISO 13485 and include the specifications for compliant development, production, distribution and maintenance of medical devices within an appropriate quality management system.
The synopsis of various international standards and integration of those standards in your internal QM-system lie within the scope of our specialization as well as the development of an appropriate documentation system.
With new regulations MDR (2017/745) and IVDR (2017/746) requirements will increase significantly - amongst others the control of supply chain and economic operators is one main focus. This will include higher efforts and levels of qualifications and monitoring which often will result in higher need for on-site audits.
CEplus is able – in co-operation with our worldwide located regulanet™ network partners - to support your auditing and monitoring in a strategic and operative way
Based on an initiative of International Medical Device Regulators Forum (IMDRF) the Medical Device Single Audit Program (MDSAP) has been established as global program which allows verification of multiple regulatory jurisdictions within a single audit of a medical device manufacturer’s QMS. The MDSAP program uses ISO 13485:2016 as the common framework, adding country-specific regulatory requirements. MDSAP audits can be performed by recognized MDSAP Auditing Organisations which includes several Notified Bodies. Currently, the MDSAP approach is supported by five countries: Australia, Brazil, Canada, Japan and the United States. The EU is still acting as an observer only.
The participating regulatory authorities hope to achieve more consistency among the auditing organisations. Even though the effort of a MDSAP audit should not be underestimated this approach hopefully leads to an overall reduction of inspection time for medical device manufacturers.
CEplus provides the relevant support