In the “Medical Devices” field, a Medical Device Single Audit Program (MDSAP) is used to check and assess compliance with the relevant requirements specified by the participating regulatory authorities, the International Medical Device Regulators Forum (IMDRF). MDSAP compliance is based on the recognized international standard ISO 13485.
SwissPharmAudit® has a team of qualified consultants and auditors who can support you in preparing for an official Medical Device Single Audit Program (MDSAP) by conducting an initial audit and advising, training and preparing you on the path to audit readiness.
For manufacturers of medical devices, the ISO 13485 audit – to be carried out only by accredited agents – is the most important audit to check MDSAP compliance. The accredited agents may only issue an ISO 13485 certificate or an Annex II certificate if you have successfully passed this audit. These certifications are in turn the prerequisite for a conformity assessment according to Annex II of the Medical Devices Directive and thus for the legal marketing of the products.
Depending on the focus of the audit, this may involve:
- system audit (e.g. for conformity of a quality management system with the requirements of a standard such as ISO 13485 or ISO 9001)
- process audit
- product audit
- software audit.
We would be happy to support and advise you individually as part of the implementation of your audit/audit program.