About The Technical File Consultant Service
The Medical Device device manufacturers are advised to start working on revising the CE Marking Technical regardless of Notified Body. The (Medical Device Single Audit Program) MDSAP Consultant is designed to quality system compliance and it is allowing device companies to meet requirements in participating markets through a single audit. Now that the pilot phase of the program is over, more companies are seeking MDSAP Consultant certification to expand their market reach. This Certificate will be issued by Notified Body after a thorough review of Technical File Documentation. Ø Technical File Consultant Service The Technical File Consultant should be prepared and submitted to Notified Body by the manufacturer. The new Medical Devices Regulation and In Vitro Diagnostic Regulation and it has a lot of additional requirements compared to MDD which is explained. Technical File Consultant has gained sufficient knowledge via training, Internal debate, Conferences abou