Development of medical devices

We develop medical devices – from concept to market launch

When a tiny volume of premature infant’s lungs, about the size of four sugar cubes, needs to be reliably ventilated, you need a partner on your side who specializes in the development of highly sensitive medical equipment.

IMT develops innovative systems, devices, and software for the world’s leading medical technology companies. To do so, we draw on our expertise based on numerous projects and accompany you from strategic consulting to a market-ready product.

Our know-how stems from development projects for medical devices that require the highest levels of safety and reliability. Our designs are used in the following clinical fields: respiratory medicine, anesthesiology, patient monitoring, ophthalmology, microsurgery, electromagnetic therapy, dentistry, and others.

Have we piqued your interest? Learn more about our projects and how we approach the requests of our customers.

Wound therapy device

Air compressor

Patient monitor

Anesthesia workstation

Humidifier for patient ventilator

Surgical microscope

MR-compatible ventilator

Patient ventilator

Therapeutic retinal laser

Vascular therapy devices

Our Business Development team will be happy to provide you with a consultation.
Get in touch with us now.

Kontakt mm
Dr. Maxim Mamin
Head of Business Development
+41 81 750 09 58
Kontakt bb
Benno Bieri
Business Development Manager
Medical Devices
System Engineering
+41 81 750 06 31

Concept creation

You have a vision and are looking for professional know-how as well as support in the concept phase? We develop a sound basis for your decision-making, so that your vision becomes reality

Our core competences include:

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Brainstorming

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Proof of concept
(3D models, Mathlab/Simulink
simulations, rapid prototyping)

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Definition of system and
software architecture

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Requirement engineering and
test strategy

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Creation of a development
roadmap

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Calculation of development
and production costs

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Evaluation and qualification
of components and
suppliers

Product development

When you’re ready to move from concept to product development, your project will be in good hands with IMT. Thanks to our experience in the development of medical devices, we design the development process efficiently and oversee it competently. This enables you to launch a new product on the market in a short time.

We work in accordance with current medical technology standards
and regulatory requirements:

  • MDR and 21 CFR Part 820 FDA
  • ISO-13485 QM-certified development process
  • ISO 14971 Risk management
  • IEC 62304 Software development
  • FDA and IEC 62366-1 Usability of medical devices
  • Medical device cybersecurity
  • IEC 60601 Electrical Safety, EMC
  • IEC 61508 Functional safety

Our standardized development process is divided into the successive phases of the V-model. It ensures that the process runs smoothly.

V-Modell der IMT

We also provide support for the following tasks:

  • Launch of production including test equipment and validation
  • Optimization of internal processes and tools for development
  • Consultation during test automation
  • Review and analysis of concepts, designs, and software code

Value engineering

As experienced medical technology specialists, we can support you in mastering value engineering. This will enable you to concentrate on the development of pioneering innovations.

We can support you with:

  • Further development of existing products
  • Replacement of obsolete components
  • Integration of new product components
  • Cost reduction initiatives

Regulatory and quality services

Our Regulatory Team knows the regulatory requirements applicable to medical devices worldwide and will assist you in getting your devices successfully registered. We collaborate regularly with the international standards committees and have access to a wealth of know-how.

We will guide you through the following regulatory strategies for new projects:

  • Evaluation of applicable standards and directives
  • Creation and improvement of Quality Management systems
  • Gap analyses of existing technical documentation and closing of any gaps
    closing of any gaps
  • Definition and organization of verification and validation
  • Approval in accordance with the Medical Device Regulation (MDR) in
    Europe, FDA guidelines in the USA, Health Canada regulations in Canada, etc

 

Contact our quality and regulatory experts and request a consultation.

Beat Keller
Head of Regulatory Affairs
Head of Quality Management
+41 81 750 06 38

Customers

We have successfully implemented more than 500 projects for over 100 clients,
among others for the following companies:

Unsere Kunden - Entwicklung von Medizintechnik