Legal Manufacturer and Regulatory Consulting for Medical Devices and IVD in over 30 countries

BAYOOCARE GmbH

Darmstadt (Headquarters) · Berlin · Munich · Basel (CH-Rep) · London (UK Representative)New on Amplifa

2–10Employees

5Locations in Germany, Switzerland and the United Kingdom

over 30Target countries for market placement

over 10 yearsExperience in placing medical devices on the market

About BAYOOCARE

BAYOOCARE is a service provider for placing medical devices and in-vitro diagnostics on the market, headquartered in Darmstadt. As Legal Manufacturer, the company assumes full manufacturer responsibility under the MDR and IVDR – from classification and CE marking through technical documentation to post-market surveillance. This includes product liability, vigilance and pharmacovigilance processes, the coordination of technical tests (EMC, IEC 60601, biocompatibility, IEC 62304, IEC 62366) and the organization of communication with Notified Bodies. In addition, BAYOOCARE offers launch strategy, international market development, quality management support and regulatory affairs consulting. With locations in Darmstadt, Berlin, Munich, Basel and London, the company operates as EU Authorized Representative, CH-Rep and UK Representative; its customers' products are present in more than 30 target countries. Further industries with specialization are digital health applications, pharma and cosmetics compliance.

Site: Darmstadt
Processes: Legal Manufacturer as a Service (legal manufacturer for medical devices), EU Authorized Representative / Authorised Representative (EU, UK, CH), Launch strategy, Regulatory Affairs consulting, Distribution / international market development, Product liability, Vigilance, pharmacovigilance and post-market surveillance (PMS/PMCF), Technical tests and testing (EMC, IEC 60601, biocompatibility, IEC 62304, IEC 62366)
Materials: MDR Compliance (EU Regulation 2017/745), IVDR Compliance, Software Validation according to IEC 62304, Usability Testing according to IEC 62366, Electrical Safety according to IEC 60601, Post-Market Surveillance and Vigilance, HTA Regulation Support (JCA), Cosmetics Compliance (Regulation (EU) 2023/1545)
Certificates: ISO 13485:2016, MDSAP, ISO 27001, MDR Conformity Certificate Class IIa, MDR Conformity Certificate Class IIb, ISO 13485:2016 (TÜV Süd), MDSAP (TÜV Süd), MDR Certificate Class IIa, MDR Certificate Class IIb
Employees: 2-10
Industries: Medical technology / Medical devices, In-vitro diagnostics (IVD), Digital health applications / Software as a Medical Device, Pharmaceuticals, Cosmetics

01
Launch strategy and classification
02
Technical documentation according to MDR/IVDR
03
Coordination of technical tests
04
Communication with Notified Bodies
05
Legal manufacturing and product liability
06
Distribution and international market development
07
Vigilance and post-market surveillance

Services and Processes

MDR

MDR Compliance (EU Regulation 2017/745)

Full regulatory responsibility including CE marking and conformity assessment procedures for medical devices.

IVDR

IVDR Compliance

Market placement of in-vitro diagnostics under the European Regulation.

IEC 62304

Software Validation according to IEC 62304

Implementation of required tests for software as a medical device, including classification under Rule 11 of the MDR.

IEC 62366

Usability Testing according to IEC 62366

Coordination of usability tests for medical devices.

IEC 60601

Electrical Safety according to IEC 60601

Organization of electrical safety tests at testing laboratories.

PMS

Post-Market Surveillance and Vigilance

Systematic risk assessment, incident reporting and PMCF after market launch.

HTA

HTA Regulation Support (JCA)

Support with Joint Clinical Assessments and clinical evidence under the EU HTA Regulation.

KOSMETIK

Cosmetics Compliance (Regulation (EU) 2023/1545)

Review of fragrance allergen labeling and product documentation.

Locations

Darmstadt

Headquarters

Materials: Legal manufacturing, Regulatory Affairs, technical documentation

Berlin

Location (EU Authorized Representative / Legal Manufacturing)

Munich

Location (EU Authorized Representative / Legal Manufacturing)

Basel

Location (CH-Rep / Swiss Authorized Representative)

London

Location (UK Representative)

Core Services

**Legal Manufacturer as a Service – Manufacturer Responsibility for Medical Devices**Legal manufacturing · Medical technology

**Service Portfolio from Launch Strategy to Post-Market Surveillance**Regulatory Affairs · Medical technology

**Compliance Service for Medical Devices**Regulatory Consulting · Medical technology

Inside the production

Industries

Medical technology / Medical devicesIn-vitro diagnostics (IVD)Digital health applications / Software as a Medical DevicePharmaceuticalsCosmetics

Additional services

Legal Manufacturer as a Service (legal manufacturer for medical devices)EU Authorized Representative / Authorised Representative (EU, UK, CH)Launch strategyRegulatory Affairs consultingDistribution / international market developmentProduct liabilityVigilance, pharmacovigilance and post-market surveillance (PMS/PMCF)Technical tests and testing (EMC, IEC 60601, biocompatibility, IEC 62304, IEC 62366)Quality management support (QMA, internal audits, mock audits, QMS setup)Communication with Notified BodiesTechnical documentation according to MDR/IVDRCosmetics compliance (fragrance allergen labeling)HTA Regulation Support (Joint Clinical Assessment)

Quality and Certification

BAYOOCARE is certified according to ISO 13485:2016 and MDSAP by TÜV Süd and holds ISO 27001 as well as MDR conformity certificates for Class IIa and IIb. Quality assurance includes internal audits, mock audits and setting up quality management systems at customers.

Evidence	Darmstadt
ISO 13485:2016 (TÜV Süd)
MDSAP (TÜV Süd)
ISO 27001
MDR Certificate Class IIa
MDR Certificate Class IIb

History

Over ten years of experience in placing medical devices and IVD on the market (according to website)
Receipt of EU Regulation 2017/745 certificates for Class IIa (Companion Med App) and Class IIb (NeoDoppler)