Navigate your start-up safely through the regulatory maze

As a young MedTech company, BAYOOCARE accompanies you from the initial product idea to the market launch – so that you can concentrate on development.

BAYOOCARE ist Legal Manufacturer as a Service, Legalhersteller für Medizinprodukte in über 30 Ländern
BAYOOCARE ist Legal Manufacturer as a Service, Legalhersteller für Medizinprodukte in über 30 Ländern

Navigate your start-up safely through the regulatory maze

As a young MedTech company, BAYOOCARE accompanies you from the initial product idea to the market launch – so that you can concentrate on development.

Your journey at a glance

Product idea

Classification & purpose

Development

ISO 13485, Tech. Documentation

Authorization

CE marking, notified body

Market launch

Launch, EU, CH, UK, USA

Post-Market

PMS, PMCF, Lifecycle

Our services for start-ups

BAYOOCARE - Legal Manufacturer as a Service

  • Regulatory advice

  • Establish QMS

  • Joint advice & support

Still have questions? Please contact uswe know the answer.

Regulatory advice & approval

We help you to understand and correctly implement the complex regulations of the MDR – including technical documentation and support through the conformity assessment.

Establish QMS

We support you in implementing a customized QMS that complies with legal requirements and structures your business processes properly right from the start.

Joint advice & support

Our collaboration is based on trust and transparency. Together, we develop solutions that are precisely tailored to your situation – from planning to implementation.

BAYOOCARE - Alfred Koch - CEO & PRRC

Alfred Koch

CEO | PRRC

How to contact us

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.

Contact form

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