Hardware development for medical technology
We develop and verify hardware that meets regulatory requirements – efficiently and with regulatory approval. Together we will bring your medical device to market faster.
Our services at a glance
We offer all relevant services for the development of hardware in medical technology. From the Requirements analysis and design above Mechanical and electronic development, Prototype construction, Verification and validation up to Documentation that complies with manufacturing and standards. We will accompany you throughout the entire development process with proven methods and a certified quality management according to EN ISO 13485. This is how we ensure that your hardware reliable, secure and suitable for registration is – from the initial idea to series production.
Requirements Engineering & Architecture
- Analysis of relevant standards and regulatory requirements
- Derivation of specific hardware requirements
- Risk analysis and definition of safety-relevant functions
- Architectural design, block diagrams, interface concepts
- Creation of concepts and functional prototypes
Hardware development & circuit design
- Development of analog and digital circuits
- High-speed design, mixed-signal systems, EMC-compliant layout
- Simulation with LTspice, QSPICE, Altium, KiCad or your tool
- Prototyping and Design for Manufacturing (DFM)
Verification & Validation
- Functional and safety-related tests
- EMC testing, environmental and lifetime testing
- Creation of complete test documentation
- Full scope of services during development from our Test Lab
Technical Documentation & Approval
- Preparation of approval-relevant documents in accordance with IEC 60601-1
- Support with certification and regulatory processes
- Providing audit-proof evidence
MEDtech engineer as partner
You benefit from our in-depth expertise and many years of experience in the field. own development and production medical hardware. The processes and quality standards established in this process are available to you today as reliable and proven service available.
We are developing Hardware, which are perfect for your product, Your Requirements and your Pursue fits. From the Concept phase above Prototyping up to Ready for series production We will support you flexibly, on a case-by-case basis or as a whole long-term development partner.
Thanks to efficient development processes, precise measurement technology and proven validation processes We deliver fast, reliable and standards-compliant results – from the initial idea to the finished component.
They are in direct contact with our Hardware developers and Project manager. This allows you to contact us quickly, easily, and professionally at any time. technical questions, design details or solutions Exchange information – completely without bureaucratic hurdles.
References
"We appreciate the constructive, goal-oriented, and reliable collaboration. This allows us to achieve our goals together within the set framework."
- LRE Medical GmbH
"The collaboration with MEDtech Ingenieur GmbH was extremely professional and efficient. We are very satisfied with the results."
- Siemens Healthineers AG
"As a young medical technology startup, we benefited enormously from the expertise, reliability, and flexibility of the entire team. The straightforward communication made the collaboration particularly efficient. A clear recommendation—an ideal partner, especially for startups!"
- Eversion Technologies GmbH
""We have been working successfully with MEDtech Ingenieur GmbH for many years and appreciate their outstanding development and production services for medical devices. MEDtech Ingenieur has proven to be extremely reliable and competent, especially in the regulated sector.". Their commitment to quality and their proactive approach make them an indispensable partner in medical technology.""
- Be-on-quality GmbH
Your contact person for medical hardware
