Why Choose UK RepMed?
UKRepMed is a trusted UK company with vast experience in the manufacturing and regulations of Medical Devices. Therefore we understand your needs as a manufacturer as well as having in-depth knowledge of EU MDR. We understand the challenges and costs that the MDR has brought to manufacturers, allowing us to provide an exceptional level of service while being cost-effective.
Our partner lab is highly qualified and certified and can perform the complete biocompatibility testing needed to provide you with the Biological evaluation reports for your MDR application
The benefits to you
- Trusted UK company
- Overseen by a highly qualified professor
- Cost-effective solution
Testing
UKRepMed has all the testing services required for ISO10993. There are 24 categories of biocompatibility testing and each has its own unique requirements, many decisions need to be made for each test. Our team of experts can help guide you through these.
There are three biocompatibility tests that all medical devices must go through: cytotoxicity, sensitisation and irritation tests. However based on the category of the device up to five additional tests may be required. Download our testing matrix to see which tests are required for your devices. Our Expert team will also assist you in deciding which tests you need