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Document Drafting

We at DKNSB provide you Technical Document Services for:Document Drafting Services

  • Risk Analysis as per ISO 14971:2019
  • Clinical Evaluation as per MEDDEV 2.7.1 Rev. 4
  • Quality Management System Procedures - Integrated for ISO 9001, ISO13485, 21CFR 820, ICMED13485, MDR Schedule-Vth and MDSAP
  • Quality Manual- Integrated for ISO 9001, ISO13485, 21CFR 820, ICMED13485, MDR Schedule-Vth and MDSAP
  • Plant Master File as per WHO TRS and Schedule IVth of Indian MDR
  • Technical Files for CE Certifications
  • US FDA 510K Dossier
  • Device Master File as per Schedule-IVth of Indian MDR
  • Device History File
  • Usability File  as per IEC 62366-1:2015 /Amd 1:2020
  • Validation Master Plan
  • Qualification Protocols
  • Validation Protocols

 

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