- Able to self-certify (CE mark medical device) up to Class IIb at two Notified Bodies | Read more >
- 20+ years experience with Class I, IIa, IIb and III medical devices | Medical Device Consulting >
- 30+ Products on the Market | Projects >
- From idea to R&D to Operations to Legal Manufacturer, we handle it all | Services >
Medical Device Development
Your Medical Device on the Market? We make it happen! We are your expert partner to help you get market approval in a fast and cost effective way while you own the IP.
How we do this?
We are ready. Are you too?Get in touch
Our mission is to bring reliable medical devices to the market in a fast and cost-effective way for patients and society to benefit from. Did you know that the Dutch word BAAT translates into BENEFIT? Our mission is in our name.
We provide our customers with:
- An ISO 13485 certified and MDR & FDA compliant way of working
- Pre-validated Processes for Cleaning, Packaging & Sterilization
- A broad Industry Network of Qualified Suppliers
- Complaint Handling, PMS and PMCF services for your Product
Find out more?