Development and series production of medical devices – Hardware, Software, Design, Usability and Regulatory from a single source.
YOOme – your medical experts (BAYOONET AG)
Darmstadt · Munich · Berlin · Ludwigsburg · Cologne · Höhn · Basel (CH)New on Amplifa
About YOOme
YOOme is a corporate group of the BAYOONET Group with more than 300 employees for the development of medical devices in Europe. Manufacturers can access all services of the entire medical device journey through YOOme: idea generation, conception and requirements engineering, medical hardware and software development (DiGA, DiPA, Apps), cybersecurity, validation and verification, product design, usability and UX, industrial design, as well as regulatory consulting as a Legal Manufacturer (CH, UK, EU Rep). The portfolio also includes Post-Market Surveillance, Hosting & Cloud Service, and Support (1st–3rd Level). YOOme supports startups, SMEs, clinics, corporates, and investors structurally from the product idea through series readiness to production and market launch in more than 50 countries. Under one roof, the partner brands BAYOOCARE, BAYOOMED, Mechatronic, Puls Product Design, and UID medical software development, mechatronic system design, user experience design, industrial product design, and regulatory affairs. Locations are in Darmstadt, Munich, Berlin, Ludwigsburg, Cologne, Höhn, and Basel (Switzerland).
- Site
- Darmstadt
- Processes
- Medical Device Development (Hardware, Software, Design, Regulatory, Market Launch), System Development / Device Development / Series Production of Medical Devices, Idea Generation, Conception & Requirements Engineering, Medical Hardware Development, Medical Software Development (DiPA, DiGA, Apps), Cybersecurity, Validation & Verification
- Materials
- Medical Device Development, Medical Software (DiGA/DiPA), Usability & User Interface Design, Product Design & UX, Legal Manufacturer & Regulatory Affairs
- Certificates
- ISO 13485, MDSAP
- Industries
- Medical Technology, Medical Software (DiGA/DiPA), IVD, MedTech
- 01
Idea Generation / Feasibility
- 02
Conception & Requirements Engineering
- 03
Hardware and Software Development
- 04
Cybersecurity
- 05
Validation & Verification
- 06
Design & Usability
- 07
Market Launch (Legal Manufacturer)
- 08
Series Production & Service
Services & Processes
Medical Device Development
System and Device Development from feasibility study to series production of medical devices.
Medical Software (DiGA/DiPA)
Development, cybersecurity, and verification of medical apps and digital applications.
Usability & User Interface Design
User research, UI design, prototyping, and formative and summative evaluation.
Product Design & UX
Design analysis, design engineering, and corporate design for medical devices.
Legal Manufacturer & Regulatory Affairs
CH, UK, and EU Rep, regulatory consulting, and post-market surveillance.
Locations
Darmstadt
DELocation
Munich
DELocation
Berlin
DELocation
Ludwigsburg
DELocation
Basel
CHLocation
Cologne
DELocation
Höhn
DELocation
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Medical Device Development (Hardware, Software, Design, Regulatory, Market Launch)Engineering | – | – | – | – | – |
| System Development / Device Development / Series Production of Medical DevicesEngineering | – | – | – | Series production mentioned, none | – |
Additional services
Quality & Certification
YOOme is certified according to ISO 13485; additionally, there is an MDSAP certification as a basis for approvals in several jurisdictions.
| Evidence | Darmstadt | Munich | Berlin | Ludwigsburg | Basel | Cologne | Höhn |
|---|---|---|---|---|---|---|---|
| ISO 13485 | |||||||
| MDSAP |