BAYOOCARE

What BAYOOCARE does

BAYOOCARE GmbH is a Darmstadt-based regulatory services provider that operates a "Legal Manufacturer as a Service" model for medical device companies under EU MDR 2017/745 and IVDR. The company assumes full legal manufacturer responsibility on behalf of clients, covering classification, technical documentation, CE marking, notified body communication, product liability, and post-market surveillance, thereby enabling medical device, pharmaceutical, and MedTech startup clients to bring products to market in over 30 countries without building their own ISO 13485 quality management system. The firm's certified footprint includes ISO 13485:2016, MDSAP (covering Australia, Brazil, Canada, Japan, and USA), and ISO 27001, all audited by TÜV SÜd, alongside EU MDR certificates for Class IIa (Dräger Companion med) and Class IIb (NeoDoppler) devices.

Underlying service delivery is built on a shared certified QMS and a centralized regulatory platform supported by the MEDiLEX interactive reference tool for European medical device law. Revenue is generated through three streams: professional services (regulatory consulting and QMS support), managed services (ongoing legal manufacturer and authorized representative retainers under multi-year contracts), and project-based engagements (conformity assessments, international approvals, post-market services). Pricing is quote-based and tailored to product risk class, target markets, and scope, with no public price list.

The go-to-market is sales-led and content-driven, targeting three customer verticals (MedTech enterprises, pharmaceutical companies, and MedTech startups) via SEO-optimized regulatory content, a monthly regulatory newsletter, industry event presence, and direct enterprise outreach. The company operates eight office locations across Germany (Darmstadt HQ, Berlin, Munich, Ludwigsburg, Höhn, Köln) and Switzerland (Basel as Swissmedic interface), and is managed by three Geschäftsführer — Alfred Koch (CEO and PRRC), Stefan Becher, and Frank Manger — within the BAYOONET AG corporate group via VAT consolidation.

Name

BAYOOCARE

Legal name

BAYOOCARE GmbH

Website

https://bayoocare.com

Company type

Private

Operating status

Operating

Headcount range

1–10 employees

Short description

BAYOOCARE GmbH is a Darmstadt-based regulatory services firm that acts as a Legal Manufacturer for medical devices under EU MDR and IVDR, enabling MedTech, pharma, and startup clients to market products across 30+ countries without their own ISO 13485 QMS.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Services

NAICS

Medical Equipment and Supplies Manufacturing (33911)

SIC

Services-Health Services (8000)

akta.pro primary industry

Third-Party/Outsourced Quality & Responsible Person Services (EU QP/RP, US Agent) (HLAGAKAO)

akta.pro secondary industries

Medical Device Regulators (HLAJADAC), DTx/SaMD Regulatory, Quality & Compliance Software (QMS/ISO/FDA) (HLACANAN)

Keywords

• Medical device regulatory services
• Legal manufacturer services
• EU MDR compliance
• Quality management consulting
• Medical device authorization

Headquarters

HQ city

Darmstadt

HQ country

Germany

HQ region

Europe

Offices8 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Others

Revenue model

1. Regulatory Consulting Services: Fees for regulatory affairs consulting including product classification, launch strategy development, and conformity assessment support. Services are tailored to each client's specific needs and product requirements.
2. Legal Manufacturer Services: Ongoing fees for assuming legal manufacturer responsibility including EU/CH authorized representative services, product liability coverage, communication with notified bodies, and post-market surveillance.
3. Quality Management Support: Fees for hands-on QMS support including mock audits, internal audits, QMA support, and technical documentation review services.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

BAYOOCARE acts as a Legal Manufacturer for medical devices and in-vitro diagnostics, assuming full manufacturer responsibility under EU MDR 2017/745 and IVDR on behalf of client companies. Services span product classification, CE marking, technical documentation, notified body communication, quality management system operation, post-market surveillance, and authorized representation for the EU and Switzerland across more than 30 countries.

Product overview

BAYOOCARE is a Legal Manufacturer as a Service provider for medical devices operating across 30+ countries. The company offers a unified regulatory compliance platform providing full manufacturer responsibility under EU MDR 2017/745 and IVDR, including classification, CE marking, technical documentation, post-market surveillance, and market introduction services. Its client-facing product portfolio includes NeoDoppler CIMON Medical (Class IIb), Dräger Companion med (Class IIa), Meine Tinnitus App, MyIUS, and easyDOAC. Supplementary digital offerings include MEDiLEX (an interactive reference tool for European medical device law) and the YOOme digital health platform. The service spans EU Authorized Representative functions, CH-Rep for Switzerland, FDA preparation support, international approval, quality management, and post-market services including vigilance and PMCF.

Differentiator

Problem solved

Functional benefit

Brands

• MEDiLEX: Interactive reference work for European medical device law (MDR and IVDR) - an archived digital documentation tool.

Products and services

• Legal Manufacturer as a Service Full manufacturer responsibility for medical devices and IVDs, including classification, CE marking, technical documentation, notified body communication, and post-market surveillance. Enables clients to market products under their own brand without building an internal ISO 13485 quality management system. Targeted at MedTech companies, pharma firms, and MedTech startups seeking EU and Swiss market access.
• Regulatory Affairs & Compliance Consulting Strategic and operational regulatory support including product liability coverage, software medical device classification, cosmetic product compliance, data protection and IT security, regulatory due diligence, and strategic consulting for medical devices and digital health applications.
• EU Authorized Representative (EU-Rep) Services Authorized representative service under MDR for non-EU manufacturers placing medical devices on the European market, covering regulatory interface with EU authorities and post-market obligations.
• Swiss Authorized Representative (CH-Rep) Services Authorized representative service for the Swiss market, handling registrations, labeling, and technical documentation maintenance with Swissmedic through the Basel office.
• International Approval Services Regulatory approval support for medical devices and IVDs in international markets including the USA (FDA), Australia (TGA), Brazil (ANVISA), Canada (Health Canada), and Japan (MHLW) via MDSAP single audit program.
• Quality Management & Audits Hands-on support for ISO 13485 quality management systems including mock audits, internal audits, Quality Management Auditor (QMA) support, and technical documentation review for medical device companies.
• Post-Market Services Post-market surveillance services including vigilance, pharmacovigilance, Post-Market Clinical Follow-up (PMCF), and contract management for medical devices and in-vitro diagnostics.
• Launch Strategy for Medical Devices Strategy and execution support for the market introduction of medical devices, covering regulatory pathway design, go-to-market planning, and compliance readiness.
• MEDiLEX Reference Platform Interactive digital reference tool bundling EU MDR and IVDR legislation with cross-references and full-text search capabilities, serving as an educational and SEO asset; archived content no longer actively updated.

Quantifiable outcome

• Complete conformity assessment procedure for software medical devices within 4 weeks
• +1 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Six partnerships are on record, tiered core and minor.

• TÜV SüdcoreStrategic or Co-development PartnerTÜV Süd serves as BAYOOCARE's notified body for certifications including ISO 13485:2016, MDSAP (Medical Device Single Audit Program), and regulatory conformity assessments. BAYOOCARE has a long-standing working relationship with TÜV Süd and has established processes based on their mutual understanding of expectations and requirements. This partnership enables BAYOOCARE to offer certified quality management systems and conformity assessment services to their clients.
• SwissmediccoreStrategic or Co-development PartnerBAYOOCARE's Basel office functions as an interface to Swissmedic for Swiss market access. They handle registrations, appear on product labeling, and maintain technical documentation locally for clients seeking to place medical devices on the Swiss market.
• BAYOONET AGminorOthersBAYOONET AG is part of the same corporate group as BAYOOCARE, sharing VAT organization (USt-ID: DE253462525). This indicates a corporate family relationship rather than a strategic partnership.
• CIMON MedicalminorOthersBAYOOCARE serves as the legal manufacturer for NeoDoppler, a product from CIMON Medical. This represents a client-service provider relationship where BAYOOCARE handles regulatory compliance while CIMON focuses on product development and marketing.
• Infectopharm (for Meine Tinnitus App)minorOthersBAYOOCARE serves as the legal manufacturer for Meine Tinnitus App, a digital health product developed by Infectopharm. BAYOOCARE handles regulatory compliance and market access while Infectopharm focuses on product development.
• Dräger (for Dräger Companion med)minorOthersBAYOOCARE serves as the legal manufacturer for Dräger Companion med, a companion medical app developed by Dräger. BAYOOCARE provides regulatory compliance services while Dräger handles product development.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• NSF Health Sciences: NSF's health sciences division provides medical device regulatory consulting, QMS support, and training services. Comparable to BAYOOCARE in offering outsourced regulatory affairs and quality compliance services to medical device manufacturers navigating EU and global requirements.
• Qserve Group: Netherlands-based consultancy specializing in medical device regulatory affairs, clinical evaluation, and quality compliance under MDR/IVDR. Directly comparable to BAYOOCARE's target market of MedTech companies, pharma firms, and startups needing outsourced regulatory and notified body support.
• NAMSA: US-headquartered medical device-focused CRO offering regulatory, quality, and clinical research services. Comparable to BAYOOCARE as a medical device regulatory services provider, though broader in scope (including clinical trials) and considerably larger in scale.
• Medidee Services SA: Switzerland-based regulatory affairs and quality management consultancy dedicated to medical devices and IVDs. Comparable to BAYOOCARE in offering EU MDR/IVDR consulting, QMS support, and CE marking services to MedTech companies, including non-EU manufacturers seeking a Swiss/European regulatory partner.
• Johner Institut: German consultancy focused on medical device regulatory compliance, software medical devices (SaMD), and ISO 13485 QMS, with strong content/education presence. Comparable to BAYOOCARE in DACH-region MDR focus and SaMD expertise addressing the same MedTech startup and enterprise segments.

Broad incumbents

• TÜV Rheinland: Global testing, inspection, and certification body with medical device testing and regulatory services. Adjacent to BAYOOCARE because it operates as a notified body (similar to TÜV SÜD) and increasingly offers regulatory consulting, though as part of a broader TIC portfolio rather than a specialized MedTech-only firm.
• PharmaLex: Global regulatory affairs and compliance consultancy primarily serving pharma but increasingly medical device clients. Comparable to BAYOOCARE in providing outsourced regulatory services to life sciences companies, though at larger scale and with a pharma-first orientation.
• DEKRA: International TIC provider with medical device testing, certification, and regulatory services. Comparable to BAYOOCARE in serving MedTech clients needing MDR conformity support, but from a much larger diversified TIC platform rather than a dedicated legal manufacturer model.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/bayoocare-gmbh

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about BAYOOCARE