Person Responsible for Regulatory Compliance – PRRC Article 15 of both the Medical Device Regulation 2017/745 (MDR) and In-vitro Diagnostic
MDSAP is a single audit of your QMS by a recognised certification body, that aims to ensure the requirements of
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 IVD through the ever changing regulatory hurdles to approval.
The world of Medical Device and In Vitro Diagnostic regulations is complex. Your team need to understand the entire process,