Document Writing

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, European MDD and US FDA Quality System Regulations.

We at DKNSB 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
  • Validations Protocols.