Audit and Due Diligence

We can perform internal, supplier or pre-inspection audits in order to check the correct implementation of your Quality System according to your internal procedures, or to any standards/directives/regulations.  Internal audits are particularly important if you need to verify the status of your QS against the new ISO 13485:2016 standard.

Auditing will ensure compliance of your Quality System with the existing standards (Regulation 2017/745, FDA GMP, ISO 13485, MDSAP, CMDCAS, etc).

Merc’s activities include the evaluation of new suppliers and the development of audit plans for qualified suppliers.

We can also conduct diligence audits in case of internal reorganization, acquisition and/or merging.

 

 

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