YOOme develops your medical devices
YOOme is the largest network of companies in Europe dedicated to the development of your
medical devices. As a manufacturer, YOOme gives you access to all
services covering the entire medical device development journey: ideation,
concept development and requirements engineering, medical hardware and
software engineering, cybersecurity, validation and verification,
design, usability & UX, market authorization, and maintenance.
Security concepts, requirements analysis, system development, testing, hardware
Your MedTech project. Developed in a structured way.
From the initial product idea to series-ready development and production: YOOme guides startups, SMEs, clinics, corporations, and investors through the critical phases of medtech development with clearly structured packages. Choose the format that best suits your project’s current stage.
The Entire Medical Device Journey from a Single Source
We guide you through all five phases of medical device development, from initiation through concept, development, and validation to launch.
Under one roof, we combine medical software engineering, mechatronic system design, user experience design, industrial product design, and regulatory consulting as a legal manufacturer. This enables us to deliver safe and compliant medical devices—from usability engineering to post-market surveillance—all from a single source.
| PORTFOLIO | PRE-SCHEDULED | SCHEDULED | PRODUCTION | ||
|---|---|---|---|---|---|
| Overview of Services | 1. Initiation | 2. Concept | 3. Development | 4. Validation | 5. Launch |
 |
(Software) Feasibility Study / (Software) Component Research / Quality Management | Rapid Prototyping / (Software) Architecture / Compliance Planning / Requirements Engineering | Software Engineering / Software Verification / Risk Management / Cybersecurity | Technical Documentation / DMR/DHF / Initial Deployment / (Software) Validation | Post-Market Surveillance / Hosting & Cloud Services / 1st–3rd Level Support |
 |
Proof of Concept / Feasibility Study / Technical Due Diligence | System & Safety Concept / Requirements Analysis / Technical Risk Analysis | System Development / Device Development / Technical Risk Management / Pre-Compliance Testing | Production Transfer / Process Qualification / Pilot Run | Serial Production / Product Improvements / Service |
 |
User Research / User Requirements Analysis / Persona Definition / Use Cases | Interaction Concept / Visual UI Design / UI Prototyping / UX Testing | Formative Evaluation / Design System / UX Consulting | Summative Evaluation | Post-Market Surveillance / Marketing Support |
 |
Market Survey / Technology Research / Design Analysis & Strategy / Corporate Design Strategy | Ergonomics & Workflow Analysis / Ideas & Innovation / Functional Concepts / Design Concepts | Design Elaboration / Technical Development / Manufacturing Concept | Detailing / Design Engineering / Transfer to Engineering | Marketing Support / Production Support / Design Documentation / Product Design Manual |
 |
Regulatory & Legal Pathway / Intended Use Workshop / Risk Classification / Market Strategy | Application Review (Notified Body) / Supplier Qualification / Clinical Evaluation / Regulatory & Legal Consultation | Technical File / Contract & Supplier Management / Conducting Stage 1 & 2 Audits / Conformity Assessment | Negotiating Deviation Reports / Medical Device Registration / Expanding into New Markets | Maintaining / Performing PMS & Vigilance Duties / Liability & Legal Protection |
Your YOOme Experts
YOOme consists of the teams at BAYOOCARE ( Legal Manufacturer), BAYOOMED ( Medical Software), Mechatronic Medical Engineers ( Development & Manufacturing), Puls Produktdesign (Product Design & UX), and UID ( User Interface Design). All YOOme partners are part of the BAYOONET Group, which has more than 300 employees, and have carried out numerous joint projects, developed medical devices, and brought them to market internationally.
The benefit for you:
Close Collaboration
Thanks to our shared entrepreneurial spirit, we are a well-coordinated team working toward a common goal:
to develop your medical device in a comprehensive and safe manner. As a medical device manufacturer, you will therefore be supported throughout the entire medical device journey by a dedicated YOOme contact person.
Our partner companies can provide ad hoc support or serve as long-term partners for you, and for YOOme, the process is far from over once approval is granted: YOOme is your partner for bringing products to market in more than 50 countries, is MDSAP and ISO 13485 certified, and supports you with post-market surveillance and vigilance.
Here’s how we support you
During an initial consultation, we’ll work together to get an overview of the development or redesign of your medical device. How can we best leverage our expertise to bring your project to life? The choice is yours: Take advantage of our full portfolio as a full-service provider—from the initial idea through the end of the medical device lifecycle and beyond. Or partner with us for a specific area of development.
No matter where you are in the process: With YOOme, we have the right experts for your project.
Any questions left?
