BAYOOCARE

Your legal manufacturer for medical devices

If you want to launch a medical device internationally, you need very detailed knowledge about the regulatory approval.
With our experts from BAYOOCARE, we at YOOme help you understand and fulfill the requirements of the target markets.
We accompany you in successfully launching your medical device on the market.

We are certified according to ISO 13485:2016 and MDSAP by TÜV Süd, as a notified and certification body.
In addition, we have EU-VO 2017/745 certificates for a risk class IIb and a IIa product (NeoDoppler and Companion Med App).
As a legal manufacturer, authorized representative or consultant, we are at your side as a partner in over 30 countries – in Europe, Switzerland, Great Britain and soon also in the USA.

YOOme BAYOOCARE Legalhersteller MDSAP und TÜV Süd zertifiziert

  • Does it seem impossible to comply with all the legal requirements of your medical device?

  • Are you looking for support to identify the launch strategy to market approval for your medical device?

  • You want to be insured in case of damage? As a legal manufacturer, we will take over the liability for your medical device and take care of vigilance or pharmacovigilance.

  • Does it seem impossible to comply with all the legal requirements of your medical device?

  • Are you looking for support to identify the launch strategy to market approval for your medical device?

  • You want to be insured in case of damage? As a legal manufacturer, we will take over the liability for your medical device and take care of vigilance or pharmacovigilance.

Our services for your success

We create your medical device compliance

Simply leave regulatory issues relating to your medical device to us.
Whether regulatory affairs, quality and data protection requirements or other compliance issues: we keep an eye on everything for you.
With Legal Manufacturer as a Service, we offer you as a legal manufacturer an all-round service for your medical device – so that you successfully pass the conformity assessment procedure.

We accompany you during the successful market launch of your medical device

EU Rep, CH Rep, UK Rep – Wherever you are planning the approval of your medical device or in-vitro diagnostics, we will create a concept for you as part of our launch strategy, including trend analyses and product classification.
trend analyses and classification of the product classification.
At YOOme, our BAYOOCARE experts leave nothing to chance – for the successful launch and marketing of your medical device.

In the case of damage, we are liable, not you

Your product safety is our top priority.
If liability issues do arise, you can rely on us completely.
As a legal manufacturer, we assume liability for your medical device and take care of vigilance or pharmacovigilance.

An overview of all services for your medical device

Legal Manufacturer as a Service

Regulatory & legal consulting

Liability & legal liability

Conformity
assessment

Launch & Market Strategy

Clinical Evaluation

EU-, CH & UK-Rep

Registration of your medical products

Opening up new markets

Post-Market-Surveillance (PMS)