Medical Technology

MedTech is a dynamic industry that keeps on growing due to evolving technologies. The needs of an aging population and the trend of consumerization bring about new kind of personalized and connected appliances and wearables. Augmented reality and 5G open up new possibilities in operating rooms as well, and has accelerated the pace of digitalization and the demand for remote services even further.

However, the length of time to market, extremely strict legislation and the requirement for ultimate usability bring challenges to MedTech organizations and project funding. Designers must have a multidisciplinary understanding of, among other things, engineering, software, testing, cyber security and documentation. Having an excellent track record of designing and commercialization of medical products, Etteplan can help you with all of the above

Etteplan has extensive experience in the design engineering of medical devices, as well as in related regulatory issues and technical documentation. We have designed in vitro diagnostic (IVD) devices, point-of-care monitoring devices, diagnostics, rehabilitation aids, dental equipment, respiratory devices and surgical instruments, to name a few.

Etteplan has extensive knowledge of design and market entry of medical devices. We can help you in areas from concept creation to production, taking care of the regulatory issues, speed up the validation process, and produce the necessary technical documentation. We ensure fast and cost-effective market entry for our medical devices while making sure that the devices meet the demands of extreme safety and usability. Once the product is in the market, we can also take care of its life cycle management all the way from software updates, to new releases and possible redesigns. 

Design and development: Thanks to our comprehensive engineering design expertise, we support our customers in mechanical, electronics, software and hardware design, along with industrial design and manuals. We have competence in carrying out product development projects in all MDD/MDR and FDA classes and our competence includes software design according to IEC 62304.

Accelerated digitalization: Etteplan enables the digital transformation of the medical technology industry providing end-to-end solutions in the areas of research and development, production, maintenance and after sales. Our expertise covers, inter alia, connectivity, AI, cloud technologies, apps and embedded technologies. Taking advantage of our in-depth expertise in the latest technologies, such as 3D printing, digital twin, embedded platforms, robotics and automation can lead to significant savings in product development and catalyzes the production process.

Regulatory issues, testing and quality assurance: Etteplan's quality management systems are ISO 13485 certified. Our ISO 13485:2016 certification is useful especially for smaller companies and start-ups, as they do not necessarily need a full-fledged quality system of their own. We also provide our customers with product quality assurance services, including software test automation, cyber security, simulations, accredited laboratory tests and failure analysis. Our testing facilities are accredited according to e.g. IEC 60601-1-2, version 4. We also provide integration and verification tests, and we support our customers during validation.

Excellent technical product information: Etteplan is a one-stop partner for all your documentation needs, including advanced e-learning services, training and marketing materials as well as all patent-related documentation and translations. We have a long track record in creating, managing and publishing high-quality technical product information that ensures compliance with regulatory requirements, including FDA and EU Directives.

Production solutions: Etteplan maximize your production performance in terms of efficiency and quality by providing manual or fully automated assembly equipment and joining & bonding solutions. For example, production system for the accurate dispensing of fluid solutions. Click here for more information about our production solutions.