Comprehensive Medical Device Services

The comprehensive medical device service at Bharrgava Global includes:

- Test License and Manufacturing License Application

- Layout Design in accordance with GMP requirements

- Device Master Files as per Medical Device Rules, 2017

- Plant Master File as per Medical Device Rules, 2017

- Comprehensive preparation of technical documents, which includes:

  - Standard Operating Procedures (SOPs)

  - Standard Test Procedures (STPs)

  - Production verification and validation reports

  - Cleanroom validation reports

  - In-house and external validations

  - Fulfillment of training requirements

  - Equipment and instrument validation

  - Supplier management

  - Agreements with interested parties

  - Hiring of competent manpower

  - Product design file preparation

  - Artwork preparation

  - Raw material specification preparation, etc.

- Assistance with audits for manufacturing licenses

- ISO 13485:2016 and ICMED certification