MedTech product development: mechanical, electronics, firmware

Development of medical device subsystems and engineering equipment, from requirements and prototypes to verified design documentation ready for production transfer. Mechanical engineering is led by Filip Jaromczyk, electronics by Patrick Keller, with more than ten years in MedTech electronics.

Talk to us: [email protected] • +41 783 20 66 33

When this is a good fit

A new device, accessory or subsystem needs mechanical and electronic development under design control
An existing design needs changes, for example obsolete components, EMC findings or new requirements
R&D needs engineering capacity with regulatory experience for a defined work package
Verification is planned, but test methods, test equipment or evidence are missing

What we deliver

Requirements, architecture and risk inputs for mechanics and electronics
Mechanical design in CAD, tolerance analysis, prototypes
Circuit design, PCB layout and embedded firmware
Design for IEC 60601-1 electrical safety and IEC 60601-1-2 EMC
Usability engineering inputs to IEC 62366-1
Pre-compliance testing, verification planning and test execution
Design documentation and transfer to production

How a development project runs

Requirements and architecture: agree scope, interfaces, risks and acceptance criteria.
Design: mechanical, circuit, PCB and firmware design with reviews against requirements.
Prototypes and pre-compliance: build, test early against safety and EMC requirements, iterate.
Verification and documentation: test protocols, execution, reports and traceability.
Transfer: manufacturing documentation, test setup and handover to production.

Certification

Certification testing to IEC 60601 is performed by accredited test laboratories. We prepare the design, run pre-compliance tests and assemble the documentation, so the lab test is a confirmation rather than the first time the device meets the standard.

Standards we work with

IEC 60601-1, IEC 60601-1-2 (EMC), IEC 62366-1, IEC 62304
ISO 13485, ISO 14971, FDA 21 CFR 820 (QMSR)
ISO 10993 (biocompatibility input for materials and patient contact)

FAQ

Can you work inside our quality system?

Yes. We document in your templates and follow your design control process under ISO 13485 and FDA 21 CFR 820.

Can you take over or change an existing design?

Yes. We start with a design and documentation review, assess the change impact and then update design, tests and documentation.

On-site or remote?

Design and documentation work is mostly remote. Reviews, prototype integration and testing are done on-site where needed.