HEITEC – your partner for customized medical devices
Industry-specific development, manufacturing and service expertise from a single source across the entire product life cycle.
In its innovative electronics business unit, HEITEC generates technical solutions that meet the highest standards. Our broad E2MS2 service offering fully covers electronics development, production and housing technology – all under one roof, for maximum efficiency and quality.
Our extensive experience ranges from defining the system architecture as well as developing and implementing individual components to manufacturing and integrating complete systems. All steps are closely coordinated in our Competence Center and with our specialist teams in Crailsheim and Budapest. Even after the solution has been implemented, we support our customers with long-term product support and comprehensive aftermarket services.
As an active member of several standardization committees, we are always at the forefront of technical developments and offer our customers the earliest possible access to innovations.
You can rely on our proven services to implement industry-leading medical applications:
- We have decades of experience and market-specific know-how resulting from many successful projects.
- With certified procedures according to ISO 27001, ISO 13485, EN 60601-1 and EN 62304, we consistently implement high quality standards in development and production.
- Our work is based on proven project and risk management with dedicated teams, transparent project control mechanisms and state-of-the-art framework conditions.
- Our single source services ensure coordinated processes and seamless transitions between the individual product phases as well as the integration of the most advanced technologies for customized solutions.
- Right from the concept phase, we focus on cost efficiency and investment protection. Aspects such as design for manufacturing, ease of operation and maintenance as well as future-proofing are incorporated into the planning right from the start.
- Our employees are familiar with all GMP (Good Manufacturing Practice) requirements.
- We manufacture on state-of-the-art SMD lines for sustainable production.
- With test procedures such as AOI, Flying Probe, X-Ray, functional testing, extensive verification and validation, as well as strict in-house review processes, we ensure that the solutions we deliver are of high quality and function safely and reliably.
- Continuous documentation and full traceability are a corner stone of our concept.
- Due to our global presence and expertise, we are familiar with all common certification processes worldwide and support you in complying with regulatory -requirements – whether CE, EU Medical Device Regulation (MDR), FDA, UL, PMDA, etc. – as well as with the internationalization of your products.
- With scalable procurement management and reliable second-source models based on an established partner network, we guarantee the long-term availability and future-proofing of technical solutions.
- We also provide you with long-term support after product realization, e.g. for maintenance tasks. The impact of amendments on the project are assessed and, if necessary, are immediately incorporated into further development, production, and quality testing.
- We offer comprehensive training and tutorials upon request.
- Design takeovers to ensure the availability of your products, e.g. after the loss of development and production partners, for know-how retention and obsolescence management, or for redesigns for functional enhancements, are also possible at any time.
- Due to the broad expertise in our business areas, modules, such as housing technology from our own inventory, software engineering, digitalization and robotics can be integrated from a single source if required.
- Upon request, our subsidiary HEITEC Innovations GmbH helps you to optimize your energy consumption through feasibility studies, simulation models, monitoring and sustainability reporting
- Depending on your integration requirements, we will find the best possible solution for you in terms of technology, cost efficiency and quality.
