Note: MD-RACT requires a commercial license of @RACT-Pro and comes standard with the @RACT-Pro+ license.
MD-RACT (Medical Device Risk Assessment and Categorization Tool) helps you speed up and optimize the risk identification and assessment process for clinical trials in medical devices.
This specialized RACT enables MedTech manufacturers and innovators to generate Risk Management Plans faster and easier and be well-positioned for pre and post-market audits.
Our proprietary MD-RACT library is an enhanced subset of the universal TransCelerate RACT. MD-RACT is specifically tailored to effectively de-risk clinical investigations conducted by small and mid-sized medical device companies and CROs. Thereby, MD-RACT is fully compliant to the international ISO 14155:2011 standards and the latest EU Medical Device Regulations (EU MDR).
Features at a glance:
- Comprehensive and ISO 14155:2011 and EU MDR compliant Medical Device RACT library, including medical device specific questions, risk suggestions, and risk mitigation actions
- Intuitive user-guide
- Fully customizable to fit your specific needs
- Add-on to @RACT-Pro and @RACT-Pro+
- One-time purchase for the use in a limitless number of clinical investigations
- Additionally, you receive a free 1.5-hour application training from one of our RBM experts
Key Statistics of MD-RACT:
- Risk Categories: 13
- Questions: 58
- Risks Suggestion: 131
- Mitigation Action Suggestions: 165
MD-RACT functions as an add-on to the RACT catalog library within the user-friendly @RACT-Pro and @RACT-Pro+ environment.
The MD-RACT library can be downloaded immediately after successful completion of your payment. An invoice will be automatically sent to your email address.