Testing of medical devices – we provide you with neutral proof of efficacy and safety of your product
When used properly, your medical device must not pose any avoidable risks to patients, users or third parties. As the manufacturer or your authorised representative, you are responsible for ensuring this.
The EU'S MEDICAL DEVICE REGULATION (MDR), which came into place on 26 May 2021, has reorganised the approval and monitoring of medical devices.
It aims to increase patient safety and improve transparency within the industry. The MDR introduces stricter controls for manufacturers and expands the requirements for technical documentation and clinical evaluation.
For manufacturers, retailers and distributors of medical devices, this means that their processes must be adapted and new obligations must be met in order to ensure compliance with the regulation.
OUR SERVICES:
- BIOCOMPATIBILITY ISO 10993 & ISO 18562
- CHEMICAL CHARACTERISATION
- CYTOTOXICITY & SKIN IRRITATION
- SENSITISATION (animal-free testing)
- TESTS FOR EMISSIONS (particles, VOC)
- LEACHABLES & EXTRACTABLES
- BIOBURDEN
- CLEANABILITY & DISINFECTABILITY
- END-OF-LIFE SIMULATIONS
- DISINFECTANT EFFICACY TESTING
- MICROBIAL BARRIER FUNCTION
- INDIVIDUAL TESTS & CUSTOMISED SETUPS
