Hardware
Software
Compliance
Design
system design
device development & manufacturing
The challenge
The barriers to the market introduction of devices in the healthcare sector are generally very high and pose major challenges for manufacturers and distributors. Since the introduction of the new European Medical Devices Regulation (MDR) in May 2017, the requirements for the clinical evaluation and classification of medical devices have become significantly stricter. This creates many new requirements, which have to be taken into consideration by the manufacturers. If you don’t know all the regulations, or if you don’t know how to implement them, the worst case scenario is that the conformity assessment or the market approval will fail.
Don’t let it get so far. How to overcome all potential barriers? We will be happy to support you.
How we can support you
Use our expertise to get an overview of the development or revision of your medical device in a confidential initial consultation. No matter what request you have, as a full service provider we have the right experts for your question.
We support you without difficult arrangements between different partners but with an innovative approach to the development of medical devices.
Just contact us
Who we are
Only excellent medical devices can achieve excellent success in marketing and use – that is what we are convinced of. As Medical Device Experts, it is our common goal to develop first-class medical devices for you from a single source and to introduce them to the market quickly and safely.
We are at your service – from the initial idea and seamless certification, to reliable production and post-market surveillance. One schedule, one contact partner, one goal. No ifs, no buts.
We are the Medical Device Experts, a team of the four companies Mechatronic, BAYOOMED, Puls Produktdesign and BAYOOCARE. At our locations in Germany, Switzerland and England we offer you many years of experience in the following areas:
Carsten Metzger
system design, device development and manufacturing
Medical Device Experts
Miriam Schulze
medical software and medical apps
Medical Device Experts
Alfred Koch
legal manufacturing service and product launch
Medical Device Experts
Dieter Fornoff
product design and ergonomics
Medical Device ExpertsReferences
With over 1000 person years of project experience in the regulated CE & FDA environment and 800 medical technology customers, we are the most experienced team of experts for the development of medical devices and medical software in Europe. Benefit from our know-how and give us the opportunity to discuss your project idea and identify possible pitfalls in a free confidential consultation. Tell us your vision and we will tell you how it can become a product.
Do you have questions?
Do you have specific questions? Or do you need general support? Get to know us as a reliable partner for successful development.
Just contact us.
