According to a KPMG survey, “58% of regulatory and quality leaders from more than 200 medical device companies do not have a strategy in place to remediate gaps in their clinical data or processes for collecting data”.
Clinical studies will play a more significant role in your risk management
Therefore, you should improve visibility and traceability of your product data, documents and technical files.
This is simply the most efficient way to ensure that the product data is ready for auditing and compliance with the EU MDR.
With Medical Device PLM, you will get:
- Increased visibility in data and processes
- Improved traceability from Design Input to Verification and Validation
- Risk Management as an integrated part of the Design Controls
- Not only a QMS system, but one system for all Product Data and related processes
Read more in this whitepaper: