Your legal manufacturer of medical devices in over 30 countries

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.

EU Rep | Europe CH Rep | Schwitzerland UK Rep | Great Britain

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.

We are MDSAP and ISO 13485 certified

By TÜV Süd as a notified and certification body, we are certified in accordance to ISO 13485:2016 and MDSAP – and can therefore provide you with a simplified marketi launch in Australia, Brazil, Canada, Japan and the USA. In addition, we are EU-VO 2017/745 certificate holders of a risk class IIb and a IIa product (NeoDoppler and Companion Med App).

Find out more: Opportunities of the Medical Device Single Audit Program (MDSAP) for manufacturers?

Read everything you need to know in our article.

Logos MDSAP und TÜV Süd

Legal Manufacturer as a Service: How we support you

BAYOOCARE has been an expert in launching medical devices and in vitro diagnostics on the market for over 10 years. Our catalogue of services as a legal manufacturer is individually tailored to you and your needs. Do you still have questions? Contact us, we might know the answer.

  • launch strategy

    create a concept, incl. trend analyses and classification of product classification

  • product liability

    take over of the product and legal liability

  • hands-on-support

    support as QMA for internal audits, mock audits, in QMS, PHAC (Public Health Action Cycle)

  • organisation & communication

    organise and communicate with the notified body (TÜV Süd)

  • technical documentation

    create and maintain the technical documentation according to MDR and IVDR, incl. revision of existing documents

  • technical examination

    carrying out technical examinations, for example at test laboratories such as EMC

  • testing

    implement necessary tests, incl. testing against alarm standards

  • distribution

    organise the distribution of your medical device in different countries

  • vigilance and pharmacovigilance

    monitor and assess post-market risks

  • post-market-surveillance (PMS)

    carry out post-market surveillance (PMS) and post-market clinical follow-up

Your journey

Do you want 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 is as individual as your requirements.

Medtech

Pharma

Start-Up

Our journey – products and projects

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”.

FlowCyclo®

Find out more about menstruation? Users can do this simply via app, with the validated and certified FlowCyclo®.

easyDOAC

Pharmacological information on the selection, prescription and use of medicines – via our progressive web app (PWA) easyDOAC

MyIUS

Track menstruation to get a prediction of a bleeding profile and information about the hormonal IUD – with the MyIUS.

News

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.

Who we are

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).

Alfred Koch

Alfred Koch

CEO I PRRC
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