Your MDR compliance. Our medical expertise.
Download our free Mastering the MDR White Paper — Our easily digestible summary of the EU MDR
The MDR is an opportunity, not a barrier
The correct approach to MDR compliance can secure market position, differentiate your products from the competition and drive commercial success.
Our team of medical doctors will help demonstrate the clinical value of your products.
We will produce a tailored MDR compliance strategy to meet all your regulatory requirements.
The right approach to MDR compliance now will help you stand out from the competition in the future.
Read more about us and our philosopy
Use our MDR Requirements Matcher to see which GSPRs apply to your products
Keep up to date with our thoughts on the industry. All our articles
Simplifying the challenges posed by the new EU MDR
Our CEO Dr Paul Hercock was invited to speak on a Kaizen Life Sciences podcast about the challenges posed by the new EU MDR.
Why medical doctors can drive MDR compliance
Working with the MDR requires knowing how to work with clinical evidence. Medical doctors are perfectly positioned to meet this requirement.
Software as a medical device
Unless you have spent time working with medical device legislation in the past, the idea that software could be a medical device may be rather unexpected.