Whether you're a startup or a large company, we help you get your medical device or diagnostic product ready for the market – safely and efficiently. From small tasks to full projects, we're here to guide you.

We help you set up and maintain a solid quality management system (QMS) that meets ISO 13485 and other key standards. From supplier audits to employee training and production support – we make sure everything runs smoothly.

Worried about all the rules and paperwork? We’ve got you. We help with everything from CE marking and product classification to talking with authorities and getting your files in order.