As a long-term cooperation partner, we accompany product development from the idea to the marketability of the medical device. The providers of ideas are, among others, start-ups, SMEs, corporations, research facilities, universities and doctors.
Specification & Proof of Concept
The development of the specification and the risk analysis together with our customers is the first and most important step in the development of the device.
Here, the product-specific requirements are formulated considering the risk class, relevant standards for the respective products are gathered, company-specific requirements for the cooperation with partners and suppliers (design input) are determined and the feasibility of the project is examined.
Concept & Architecture
Through the feasibility studies, we elaborate an implementation concept for the project, which takes into account both the market as well as the licensing requirements. How a medical device is composed and how the components are related to one another via their interfaces is described in the system architecture.
Development & Implementation
In various steps leading to the elaboration of the solution, our engineers develop the hardware and software of the medical device by involving and controlling external development and production partners. Each development phase, as required by EN ISO 13485, ends with a review of the development results.
Integration & Verification
After connecting hardware, software, mechanics and design into a unified system, the development result (design output) is verified by us against design input, in consideration with documented changes. We are glad to support the medical device placer on the market with acceptance tests for validation of the requirements and the approval of the medical device.
With products from the pilot series ready, the product evaluation can be carried out. By evaluating the experience gained and by reviewing the general usability as well as serviceability, we achieve the readiness for production of the developed object.
Already during development, we respect the production processes, which are carried out in-house according to international standards. Our quality assurance accompanies products from the goods receipt to the ready-for-dispatch, specified finished goods.
Experienced OEM / service provider for developing and manufacturing of medical devices
Safety and technical functionality are prerequisite. These days however, clients call for products which are convincing in every respect – among others usability optimization, ergonomic user-interfaces and designs which are aligned with their markets.
All requirements integrated into one comprehensive solution
Our fully integrated BYTEC approach encompasses even more: we incorporate clinical processes into the workflow, thus realizing each element of a project under the banner „made in Germany“.