After development, products and processes must be approved. We can assist with validation and oversee required testing (e.g. for DIN EN ISO 10993). Due to our extensive experience in medical technology and pharmaceuticals, we are an expert in the rollout and implementation of effective quality management systems. We can optimise your processes, and provide an external quality management consultant as required.
Before new components are used, the materials they are made of must undergo full testing for their effects on the human body and the reliability of production processes employed must be verified. We are able to conduct biological evaluations for you by testing products to ensure the materials used are compatible for use with patients. Genotoxicity, carcinogenicity and reproductive toxicity are evaluated as well as potential interactive effects with blood, on in-vitro cytotoxicity and systemic toxicity. The validation of critical processes such as sterilisation and packaging is our speciality.
We can assist you with product and process validation and if desired can provide you with support during the regulatory approval process with the relevant authorities (including FDA). You can benefit from our experience – just ask us for advice.