The current articles in this issue
Three topics that MedTech companies and medical device manufacturers are currently dealing with – categorized by our regulatory experts
BAYOOCARE supports MedTech companies, pharmaceutical companies and international manufacturers from the initial product idea to worldwide market approval. As a certified legal manufacturer in accordance with MDR and IVDR, we assume full regulatory responsibility – so that you can concentrate on development and sales.
The Regulatory Update is part of our commitment to keeping our customers and partners up to date at all times – because regulatory knowledge is a decisive competitive advantage today.
Legal Manufacturer as a Service
Full manufacturer responsibility according to MDR/IVDR – including CE marking, technical documentation and post-market surveillance.
International market approval
From the EU to the USA and Australia to Asian and Middle Eastern markets – we know the requirements and the right local partners.
ISO 13485 & MDSAP certification
Our certifications enable simplified approval procedures in Australia, Brazil, Canada, Japan and the USA.
