CDSCO Medical Device Risk Management

For manufacturers entering or operating in the Indian market, compliance with the CDSCO Medical Device Rules (MDR 2017) is mandatory. The Central Drugs Standard Control Organisation requires robust risk management documentation as part of the Device Master File.

Since CDSCO heavily references international standards like ISO 14971, MedMI is the perfect tool to prepare your regulatory submissions for the Indian market.

Quickly generate hazard analyses, mitigate risks, and export the exact tabular formats expected by CDSCO auditors, saving weeks of manual documentation time.