Documentation

We provide Technical Documention Services related to the following:

Quality Manual- Integrated or ISO 9001

ISO13485

21CFR 820

ISO 14001

ICMED13485

Quality Management System Procedure - Integrated or ISO 9001

ISO13485 Procedures

Validation Protocols

Qualification Protocols

MDR Schedule-Vth

Site Master File as per WHO

Technical Files for CE marking

Risk Analysis as per EN/ISO 14971

Clinical Evaluation

Device Master File

Device History File

Usability File

Validation Master Plan