AQC has experienced Technical Documents Writers available to write Quality Documents for you. By working closely with you, our Continuous Improvement experts (to map business processes) and our experts can ensure that the Quality System complies with customize applicable regulations of your company.
If your Quality System well established and you only need a Experts for a short assignment. We can help you. Our Experts can provide you the customized templates as per your company requirement.
We at AQC 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 - 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 Protocol
