Engineering services for medical devices
No compromise on quality and safety. As an ISO 13485 certified provider of engineering services for medical technology, we accompany your product development from the very beginning. In doing so, we prefer to solve seemingly impossible problems and turn your innovative idea into reality. Our range of services covers the entire spectrum from the initial concept to the product ready for series production.
You have an idea for an innovative product and would like to have it checked for feasibility and the exact technical requirements evaluated? We carry out these steps within the framework of a feasibility study and create a development plan for you in accordance with ISO 13485.
We identify, specify and review the requirements of all stakeholders for you so that you are ISO 13485 compliant. This is the only way to develop a medical device that meets the needs and wishes of all stakeholders.
We implement your component or the complete medical device. According to your wishes, we work according to your own product development process or according to our lean and ISO 13485-certified processes. Our software development processes meet the requirements of DIN EN 62304.
Verification & Validation
As part of the verification process, we prove that the product developed for you complies with all specified product requirements and the relevant standards (in particular the EN 60601 family). For this purpose, we work together with accredited testing laboratories. We validate your product to prove that it meets all the requirements for use.
We are happy to establish production processes and procedures for you. This can be done in your production facilities or at a contract manufacturer.
Parallel to the development, we analyze risks according to DIN EN ISO 14971 and define measures for risk mitigation. We are also happy to support you in the risk management of your in-house development.
From the very beginning, we develop with the focus on the usability of your product. For this purpose, we conduct formative and summative usability studies according to DIN EN 62366.
We prepare your clinical evaluation in collaboration with external experts in accordance with MEDDEV 2.7/1 and the rules of the MDR.
MR compatible products
Our company’s core competence is the development of MR compatible medical devices. We master their requirements and bring your device into the MR!