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Person Responsible for Regulatory Compliance – PRRC Article 15 of both the Medical Device Regulation 2017/745 (MDR) and In-vitro Diagnostic

Medical Device Single Audit Program (MDSAP) is a single audit of your QMS by a recognised certification body, that aims to

A quality management system (QMS) is defined as a system of processes that ensures a high-quality approach and consistent results

Advena are the only consultancy team you need to bring your In-Vitro Diagnostic Regulation (IVD)  through the ever changing regulatory

The world of Medical Device and In Vitro Diagnostic regulations is complex. Your team need to understand the entire process,

Internal Audits To ensure impartiality and compliance, Advena are able to offer a tailored auditing service to the challenging requirements