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Device Master File means detailed information concerning the product which is to be submitted to relevant regulatory authority made in accordance with the requirements of Part III, Appendix I of medical device rule 2017.
The device master file shall be prepared by the medical device manufacturer for each medical device or medical device category and must be presented in such a way that it is clear, organized, readily searchable, and unambiguous, to demonstrate the safety and performance of medical device.
The device master file has to be prepared for all the classes of medical device – Class A, Class B, Class C and Class D and the files have to be submitted to CDSCO for review.
Contents of Device Master File:
1. Executive Summary
2. Device description and product specifications
2.1. Descriptive information
2.2. Product Specification
2.3. Reference to the previous or similar generation of device
4. Design and Manufacturing Information
4.1. Device Design
4.2. Manufacturing Process
5. Essential Principle Checklist
6. Risk Analysis and Control Summary
7. Verification and Validation
7.3. Medicinal Substance
7.4. Biological Safety
7.6. Software verification and validation
7.7. Animal studies
7.8. Stability Data
7.9. Clinical Evidence
7.10. Post Marketing Surveillance Data
Batch Release Certificate
Certificate of Analysis
Want to prepare a Device Master File as per the requirement of Indian MDR 2017?
If your answer is yes, you probably have lots of questions about the preparation of device master files.
We at Maven Profcon Services LLP, shall give you all the answers.
Our regulatory consultants in Maven who are experienced in various fields of Medical Device Regulations are well versed in taking care of documentation like clinical evaluation, Benefit-Risk Analysis, validations, design and development files, shelf life stability study, usability engineering file, safety and biological evaluation, and chemical characteristics evaluation.
Our regulatory consultants help you in identifying requirements as per Indian MDR 2017, helps in clinical evaluation and also in post-marketing activities, risk analysis, and quality management implementation.