Placing your medical device on the market – successful market launch
Your medical device is ready to be placed on the market? Then our YOOme partners at BAYOOCARE will support you in successfully launching your medical product in over 30 countries. TÜV Süd, as the notified body and certification body, has certified BAYOOCARE in accordance with ISO 13485:2016 and MDSAP. The best conditions for launching your product on the international market.
And the best thing? We will not simply pass you on. With our joint brand YOOme, we provide support throughout the entire life cycle of your medical device – from the idea to the end of the life cycle, i.e. also beyond From market introduction to post-market surveillance, all from a single source.
YOOme: How you benefit from our partner when placing on the 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 all your to-dos from the launch strategy, through concept development including trend analysis, to classification within a product class.
Medical device compliance
Do you have questions about regulatory affairs, quality and data protection requirements? Or would you like a consultant on compliance issues? You have the choice: you can either commission our YOOme partner in full or consult them for advice.
Product liability
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.