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
Validation Master Plan
Alpine Quality Consultants a Technical Consultancy Service Company for Healthcare Industry founded in 2013 by the Group of Visionary Professionals. The company has grown organically into the technical consultancy in the healthcare industry. In today's cost competitive and increasingly stringent regulatory environment, many companies are choosing to outsource solutions. In many smaller companies, QMS tasks are often added to the responsibilities of personnel who do not have the time, knowledge or experience to handle them. As a result, regulatory compliance and ongoing quality management system/improvement often do not receive the attention it requires.