We Provide services for preparing of following technical documents during licensing process and separately-
1- Devices master files of Medical Devices
2- Quality Manual
3- Design and Development file of Medical Devices
4- Clinical Evaluation Reports of Medical Devices
5- Formats for all records and documents
6- Process of Internal Audits and it's records
7- Packaging Validation
8- Process Validation
9- Plant Master File of Premises
10- Post Market Surveillance Record
11- Risk Management file of Medical Devices
12-SOP's for all processes, machines, and other regulatory requirments
13- Training and it's records
14-Work Instructions
15- Sterilisation Process Validation & it's records
16- Projects Report
