Legal Manufacturer as a Service: Your legal manufacturer for medical devices in over 30 countries
As an experienced contract manufacturer, BAYOOCARE assumes full manufacturing responsibility for your medical device—from classification and CE marking to post-market surveillance. You focus on development and marketing; we take on overall regulatory responsibility.
Who we are
Regulatory experts with practical experience: BAYOOCARE is a company within the BAYOONET Group that specializes in medical devices. For over ten years, we have been supporting medtech companies, pharmaceutical companies, and startups with the approval and marketing of medical devices and in vitro diagnostic devices. Our team combines regulatory know-how, clinical expertise, and practical project experience—in a field that leaves little room for error.
Responsibility as a service: What sets us apart from traditional consultants: We don’t just provide consulting services; as a certified legal manufacturer, we assume full regulatory responsibility for your product. With our MDSAP and ISO 13485 certifications from TÜV Süd, as well as our ISO 27001 certification, we are well-equipped for all relevant markets. Our EU Regulation 2017/745 certificates for Class IIa and Class IIb demonstrate that we live up to this responsibility every day.
This is how we work
Regulatory Affairs is not an end in itself. We think in terms of your product: What does it need to get onto the market? What does it need to stay there? We are not consultants at a distance, but a reliable part of your team. Pragmatic, because we know that time is a scarce resource in MedTech development. Personally, because regulatory responsibility requires trust. And holistic, because compliance is not a project, but an ongoing process.
Still have questions? Please contact uswe know the answer.
Our MDSAP and ISO 13485:2016 certification from TÜV Süd offers you strategic advantages for international expansion. The Medical Device Single Audit Program facilitates market authorization in the five MDSAP countries: Australia, Brazil, Canada, Japan, and the United States. With a single audit, we cover the requirements of these key markets—saving you time and reducing the audit burden.
MDSAP builds upon ISO 13485 and expands upon it with regulatory-specific requirements. The FDA, ANVISA (Brazil), and MHLW (Japan) accept MDSAP audit reports in lieu of their own audits. The Australian TGA accepts the MDSAP certificate as proof of ISO 13485 compliance, and Health Canada uses it to maintain Canadian licensing.
Our ISO 27001 certification proves that we systematically manage information security – centrally for digital health applications and software medical devices that process personal health data. We ensure that your technical documentation meets all requirements for GDPR, data security and the basic security and performance requirements.
With offices in Germany and Switzerland, we are ideally positioned to support your international expansion. Thanks to our local presence, we understand the specific requirements and regulatory nuances of each market and can provide you with targeted support for your regulatory approval projects.
International market authorization raises many questions. We’ve answered the most common ones for you—from the role of the legal manufacturer to MDSAP certification and country-specific requirements. Can’t find your question here? Feel free to contact us.
