Germany, Switzerland, Great Britain and soon the USA – BAYOOCARE supports you as legal manufacturer, authorised representative and consultant in regulatory affairs – from the idea to the end of the product life cycle.
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Within just four weeks through a complete conformity assessment procedure with the notified body: We bring your medical software to market quickly and in compliance with the law – without compromising on safety and quality.
How do we do this? With our comprehensive expertise and our MDR certificates for medical software.
Wherever you are planning to launch your medical device – with our locations in Darmstadt, Berlin and Munich, we act for you as legal manufacturer or authorised representative within the EU. In this way, we take over all the tasks that are necessary for launching your medical device or in vitro diagnostics eion the market. With our offices in Basel and London, we are happy to take on the role of UK or CH representative.
Our experts will help you to understand and fulfil the requirements of the target countries and to launch your product successfully and compliantly. Our products can be found in more than 30 target countries, so you can benefit from our international experience.
medical device compliance
Your support: in regulatory affairs, quality and data protection requirements and advice on compliance issues.
launch strategy
Your benefit: We offer Legal Manufacturer as a Service and develop the appropriate strategy with you up to market approval.
product liability
Your advantage: As a legal manufacturer, we assume liability in the event of damage to or caused by the medical device.
Do you need comprehensive regulatory information to assess a medical device company or a specific medical device project with regard to the General Data Protection Regulation (GDPR), data security and ISO 27001 compliance? Do you want to ensure that your technical documentation meets the essential safety and performance requirements and can therefore withstand a conformity assessment procedure? Are you wondering whether your Regulatory Clearance Plan can be successfully implemented at all? Then we at BAYOOCARE are your ideal partner.
We are certified by TÜV Süd as a notified and certification body in accordance with ISO 13485:2016 and MDSAP – and can therefore offer you simplified market approval in Australia, Brazil, Canada, Japan and the USA. We are also an EU Regulation 2017/745 certificate holder for a risk class IIb and a – IIa product (NeoDoppler and Companion Med App).
Would you like to set up a quality management system with your medical start-up?
As a pharmaceutical manufacturer, do you need a way to bring medical devices and software to market?
Or are you a medical device manufacturer looking for external technical support (1st, 2nd or 3rd)?
Our service for you is as individual as your requirements.
Medical technology
As BAYOOCARE GmbH, we can support you as a MedTech company in various ways in your journey to the medical device.
Pharmaceuticals
As BAYOOCARE GmbH, we support you as a pharmaceutical company in a variety of ways along your journey to successful approval and marketing of your products.
Start-up
As a young company in the field of medical technology, you face many challenges. Compliance with Regulation (EU) 2017/745 can quickly become an impenetrable jungle of regulations and requirements.
We have accompanied various products on their way to CE marking and market approval in Europe and the USA – following our principle of “first time right”.
Pharmacological information on the selection, prescription and use of medicines – via our progressive web app (PWA) easyDOAC
Track menstruation to get a prediction of a bleeding profile and information about the hormonal IUD – with the MyIUS.
What’s new? What events and topics are coming up? Here you can find out everything you need to know from us and read articles that inform you about interesting medtech topics.
BAYOOCARE is a team that achieves great things together with its partner companies under the umbrella of the BAYOONET Group. Because we offer you a complete medical product package from one partner: We design, develop, programme, manufacture and launch your medical device or in-vitro diagnostics in Germany – from the idea to the end of the product life cycle and beyond.
Do you have any questions or would you like some advice? Just contact us, so we can get to know each other (in person).
Are you planning a project or do you have very specific regulatory questions about placing your medical device on the market? No matter what phase of your project you are in, we will be happy to support you. The quickest way to contact us – feel free to write to us.