BEST CONSULTANT FOR MEDICAL DEVICES AND PHARMACEUTICAL REGULATORY, CDSCO, ISO, CE, ISI, USFDA, MDSAP, 510k, TGA AUSTRALIA & QUALITY MANAGEMENT SYSTEM CERTIFICATION

  • veteran.ecrep@gmail.com

Document Preparation

We have Experienced and Enthusiastic Professionals that help Your Organization to prepare the following Documents Customized with your Organizational Processes in Respect to Indian Drug and Cosmetic Act’s Schedule-M, Medical Device Rule 2017,European MDD/93/42/EEC Amended by MDD/2007/42/EEC, EuMDR 2017-745, IVD EuMDR 2017-746, MDASP, US FDA Quality System Regulations.

Document Preparation

We at Veteran provide you Technical Document Service of

Risk Analysis as per EN/ISO 14971:2012
Clinical Evolution as per MEDDEV 2.7.1 Rev. 4
Quality Management System Procedures - Integrated or ISO 9001, ISO13485, 21CFR 820, ISO 14001, ISO18001, ICMED13485, MDR Schedule-Vth
Quality Manual- Integrated or ISO 9001, ISO13485, 21CFR 820, ISO 14001, ISO18001, ICMED13485
Site Master File as per WHO TRS and Customized
Technical Files for CE Certifications
Device Master File
Device History File
Usability File
Validation Master Plan
Qualifications Protocols
Validation Protocols