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Medical device development – support until marketing approval

To realise innovations in a strongly regulated market environment as medical technology presents special imposes requirements on the development team. HELVETING supports your company when it is about to translate ideas to products that are approved for the market.

HELVETING manages the balancing act with distinction between safety, robustness and innovative technology. Especially modern technologies unlock a great potential for customer benefits and help you to stay on top.

In our wide palette of successfully realised projects we look back on projects as the development of a complete X-ray apparatus, the development of the mechanics for ambulatory infusion pumps, material evaluations, risk analyses, mechatronical engineering or mobile app developments with a safe Bluetooth connection.

What does medical device development by HELVETING mean?

HELVETING offers you all competences around the medical device development from a single source and acts as an extended work bench. Delayed development because of lacking resources will be finished by us. Thereby, we bring our external perspective and inputs into your developments and processes.

HELVETING is experienced in the area of the development of medical devices. We follow a process-oriented and structured methodology. These competences and our HELVETING Engineering Process (HEP), which is certified in accord with ISO 13485 and ISO 9001, are the base in order to develop your medical devices from the first idea to market approval.

What services does HELVETING offer in the area of medical device development?

HELVETING assumes for you the complete medical device development according to your business process or to the HELVETING Engineering Process and overtakes that way the overall project management or subtasks in the context of medical device development. It could concern for instance tasks in design, computation or documentation. We also gladly support you in the idea generation phase for new products and assess these ideas based on feasibility studies. On the way to market approval, we can back you up in questions about quality assurance and regulatory affairs (e.g. risk analysis, clinical evaluation and usability).

How can you HELVETING make use of the engineering service in medical technology?

The development of sophisticated products or production processes as well as their optimisation requires experience, time and a broad range of knowledge about technologies.

Technical competence, short reaction times and flexibility will become an essential competitive advantage for a successful performance in the global market. HELVETING offers you the flexibility to realise your projects with appropriate engineering resources in the time permitted. You have the option to amend your lacking resources on a short-term basis or to delegate whole packages of development. Be it in hardware or software engineering, or in design or in the consultancy of complex technical tasks.

Support by HELVETING in questions relating to safety and quality in medical engineering

The high requirements on safety in the medical engineering sector do present high challenges on the products, their manufacturing processes as well as the development processes – especially when it is about innovations. Our experienced engineers develop, with you and exclusively for you, medical devices, laboratory equipment and implants.

Our services in the development of medical technology comprise all steps from the idea finding to the industrialisation. HELVETING has itself specialised to develop products interdisciplinary and based on HELVETING’s Engineering Process in accordance with ISO 13485 in collaboration with the notified bodies.

We accompany you during the implementation of new processes in your company and support you in the quality assurance of your production, in the production planning and in value engineering studies.

Our engineers have a wide HELVETING network of other engineers from various disciplines on their side. Thus, the knowhow of our 150 engineers is available for every customer.

How does HELVETING support medical devices during the market approval?

Besides the development of your medical device, HELVETING assumes also the admission of your products in the European, American and Chinese market. We create literature studies for clinical evaluations, review technical documentations and prepare the product approval.

Our engineers are specialists in the area of medical technology and are very well versed with branch-specific requirements. The daily work with standardised engineering processes is a matter of course for them and they know the documentation requirements during the development of medical products. For the smooth admission of your products, our engineers will be supported by HELVETING’s quality engineers.

When is the interdisciplinary knowhow of the HELVETING engineers used?

Our competences are based on the special expertise of highly qualified engineers and scientists who have realised interdisciplinary and successfully projects in medical technology. You benefit from our interconnected and interdisciplinary working engineers in the area of medical engineering and especially in medical device development. This is helpful for instance in the subject of positioning systems, when there is the need to perform highly precise positioning routines in the sub-nano area.

Also our expertise in image processing offers incredible potential benefits. Be it in quality assurance, measurement technology or in diagnosis. Effects that are hardly or not at all visible can be displayed by the right optics, right lighting and the right algorithmics visibly.

The inclusion of devices in the IT environment of clinics and the connection of devices between each other offers also a huge potential in quality assurance. Thereby, the data quality and security is a decisive factor. Also the application of near field communication, for instance RFID, provides new possibilities for traceability. Our communication specialists lend your their support.

 

Methodology

  • Definition intended use
  • Classification / definition, strategy, conformity assessment
  • Product engineering, regulatory affairs, quality management
  • Admission process / marketing authorisation
  • Market surveillance / risk handling

Competences, methods & tools

  • Endoprostheses for knee, hip, vertebrae and finger joints
  • Surgical instruments for endoprostheses
  • Positioning systems for oncological applications
  • Insulin pumps