FAQ
Medical technology projects combine regulatory requirements such as MDR, IVDR and ISO 13485 with technical development in accordance with IEC 62304 and IEC 60601. YOOme supports manufacturers of medical devices, SaMD, DiGA and IVD from the initial idea to placing on the market. Here you will find answers on approval, legal manufacturer, medical software, device development and post market surveillance.
YOOme as a full-service partner
YOOme is part of the BAYOONET Group and supports manufacturers and companies from the medical technology and digital health sectors as an independent full-service partner. We support manufacturers from the initial idea through development and approval to post-market surveillance, either on a modular or end-to-end basis, depending on requirements.
We work with medical device, IVD and digital health manufacturers as well as pharmaceutical manufacturers developing medical devices, SaMD or DiGA. Companies that want to scale regulated MedTech projects efficiently and value structured, standard-compliant processes will benefit in particular.
We start with an analysis of the product idea, target markets and regulatory framework and define the scope, roadmap and roles. We then coordinate the disciplines involved through to market launch and support the process and post-market activities.
In the project, we combine UX/UI, product design, device and embedded development, medical software, regulatory affairs and production as required. You choose whether YOOme manages the entire medical device journey or supplements individual disciplines in a targeted manner.
Authorization & Legal Manufacturer
Yes, we take on EU-Rep, CH-Rep and UK-Rep functions so that your products are legally compliant in these markets. This allows you to meet regulatory requirements without having to set up your own branches and ensure communication with the authorities.
We establish and operate PMS processes with you, including market monitoring, complaint handling and vigilance reporting in accordance with the MDR. This allows you to keep an eye on product performance and risks in the field and meet the expectations of authorities, notified bodies and auditors.
Medical Software & SaMD / DiGA
With BAYOOMED, YOOme develops medical software and SaMD in accordance with IEC 62304 for various software safety classes. We set up a structured software life cycle with requirements, architecture, implementation, verification, validation and maintenance and provide auditable documentation.
We analyze classification, intended use and data flows and implement MDR requirements and standards such as IEC 62304, ISO 14971 and IEC 62366. This results in architecture, risk management and usability verifications that form a coherent story for audits and notified bodies.
We integrate maintenance, updates, security patches and feedback from the field into your IEC 62304 life cycle and your PMS processes. This allows you to keep an eye on risks and ensure MDR compliance and ISO 13485 requirements throughout the entire life cycle of your medical software.
Device & embedded development, production & testing
Embedded systems are hardware/software units that are permanently installed in the medical device and perform functions such as control, communication or data processing. They form the heart of many MedTech solutions, such as pumps, wearables or monitoring systems, and must meet strict standards.
We develop devices and embedded software in such a way that requirements from IEC 60601, IEC 62304, ISO 13485 and other standards are taken into account. We align risk management, tests and documentation with these standards to ensure approvability and auditability.
Together, we specify requirements, develop concepts and create functional and design prototypes for testing and clinical feedback. We then transfer the design to industrialization and series production with validated processes and documented traceability.
UX, Usability & Human Factors
Product Design & Industrial Design
Quality management & standards
Depending on the project, we take into account ISO 13485 for QM systems, ISO 14971 for risk management, IEC 62304 for medical software and IEC 62366 for usability. We incorporate other standards, such as IEC 60601, on a project-specific basis.
ISO 13485 defines requirements for QM systems for medical device manufacturers, such as processes, documentation and risk control. We help you to set up or further develop a QM system for medical devices that combines ISO 13485 requirements with your processes and facilitates audits.
We carry out gap analyses, structure verifications and prepare teams for questions from notified bodies and authorities. You benefit from our experience from numerous projects with MDR, ISO and IEC tests.
Your medical technology partner with a full-service approach
At YOOme, hardware, software, UX, product design and regulatory teams work together in a well-coordinated manner. This reduces frictional losses, ensures consistent documentation and accelerates your medical device journey from the initial idea to approval and production.
YOOme and its affiliated companies work on the basis of ISO 13485-certified quality management systems; individual units are also MDSAP-certified. This facilitates audits, international approvals and supplier evaluations and creates trust with notified bodies and customers.
YOOme gives you access to the services of BAYOOCARE, BAYOOMED, Mechatronic Medical Engineers, Puls Produktdesign and UID. However, you only need to coordinate with one central YOOme contact person who orchestrates all the experts for your MedTech project.
You can use YOOme both as a full-service partner for the entire medical device journey and for clearly defined sub-projects. In an initial consultation, we will clarify whether an end-to-end setup or support in selected disciplines is most efficient for your project.
Your YOOme experts
YOOme consists of the teams of 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 350-strong BAYOONET Group and have realized numerous joint projects, developed medical products and marketed them internationally.
