Placing your medical device on the market – successful market launch

Is your medical device ready to be placed on the market? Then our YOOme partners at BAYOOCARE will help you successfully launch your medical device in over 30 countries. BAYOOCARE is certified to ISO 13485:2016 and MDSAP by TÜV Süd, a Notified Body and certification body. This provides the ideal conditions for bringing your product to market internationally as well.

And the best part? We don’t just pass you along to someone else. Through our joint brand, YOOme, we support you throughout the entire lifecycle of your medical device—from the initial idea to the end of its lifecycle, including the Placing on the market through to post-market surveillance—all from a single source.

YOOme: How You Can Benefit from Our Partner When Bringing a Product to Market

EU Rep, CH Rep, UK Rep

As the representative for Europe, Switzerland and the UK, BAYOOCARE brings your medical device to market. In doing so, the experts take care of Launch strategy via concept development incl. trend analysis and classification into a product class all your To Dos.

Medical device compliance

Do you have questions about regulatory affairs, quality and data protection requirements? Or would you like a consultant on compliance issues? The choice is yours: You can either hire our YOOme partner to handle everything or bring them on board in an advisory capacity.

Product liability and vigilance

Product safety is a top priority for us. However, should liability issues arise, BAYOOCARE, as the legal manufacturer commissioned by you, can cover the risk and therefore assume liability for you. Of course, the experts also take care of your vigilance or pharmacovigilance.

One contact person for your project

Under our brand YOOme, we unite five companies, each of which is an expert in medical device development. Nevertheless, you only have one contact person who will accompany you throughout the entire process. This way, you can keep an eye on everything and can rely on us to successfully bring your medical device to market.

Carefree placing of your medical device on the market

Together, we work to the highest standards, ensuring the best quality for your medical device. We support you in bringing your medical and healthcare apps, medical software, and digital health applications (DiGA) to market and marketing them.

Together with the experts at BAYOOCARE, we offer the right service for your project. Whether as a representative, a legal manufacturer, or in an advisory capacity: How can we support you?