Committed to product performance and excellence
In order to ensure compliance for our own products, support our customers and meet the increasing regulatory requirements, we have RA/QA competence and experts within our company, which is offered through our value-adding concept Complete Performance. We offer high competence based on our long experience and continuous education within medical device standards and regulations to support and guide our customer in the regulatory world, both according to international standards as well as country specific jurisdictions.
Product certificates for own products according to EEC/MDD 93/42
Our clean rooms fulfil
ISO 14644-1, class 7
EC product certificate
ISO 13485 Cert