Document Writing Services

Alpha has experienced Technical Documents Writers available to write Quality Documents for you.

Alpha 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 Procedure - ISO 9001, ISO13485, 21CFR 820, ISO 14001, ISO18001, ICMED13485, MDR Schedule-Vth
  • Testing Procedure
  • 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 Protocol
  • Stability Study
  • Process validation