RegMetrics is regulatory compliance software that demystifies medical device regulation, guiding academics and early-stage innovators through the process step-by-step. The software is user-friendly and accessible, even for those without prior regulatory knowledge. RegMetrics can help with the regulations for both medical devices (MDR) and in vitro diagnostic medical devices (IVDR).
RegMetrics provides an objective and trustworthy approach with all its content referencing official documents, while using data driven technologies to cater to all types of medical devices from software to hardware, as well as in vitro diagnostics.
The software can be used to answer the following questions:
- Is my device a medical device?
- What is the classification of my device?
- Which part of the regulations do I have to adhere to?
- Which standards are useful to me?
- Which test houses can help me?
RegMetrics is widely used by translational research services at universities and hospitals, MedTech incubators and accelerators to support entrepreneurs on their regulatory journey.
