Quality management for medical devices: Our System for Success.

Quality management systems (QMS) play an essential role in the context of the legal requirements for the market establishment of a medical device.

There are various normative and legal requirements, such as the MDR (Regulation EU 2017/745), DIN EN ISO 13485 or FDA 21 CFR part 820, which are being continuously developed and adjusted.

Since we have our own QMS (Quality Management System), customers can implement their product into our system and thus delegate their obligation as a legal manufacturer. We provide support where you need it – from checklists to accreditation with tailored information. We take care of the quality management of your products.

We consult, design and implement systems for quality management according to the individual requirements of the respective product and the associated processes.