The need for, and the potential to create, new highly technological medical devices has inspired many research projects and companies to create new medical applications that have not been possible in earlier days. New treatments or devices for the surveillance of body functions allow patients to leave the hospital earlier and to convalesce at home. Furthermore, chronically ill patients can stay in their well known environment at home for a longer time using these devices.
Our ISO13485 certification including MDD and AIMD, and the broad knowledge on sensors, algorithms and systems in the above areas, and the experience from successful projects makes us an ideal partner for medical applications. We are further willing to help our customer in avoiding pitfalls in medical projects. The main pitfalls are the medical laws and regulations.
The European council guideline 93/42/EWG also called Medical Device Directive (MDD) 93/42/EEC, the 90/385/EWG (Active Implantable Medical Device Directive (AIMD)) and the EN60-601 are the most important ones. Additional Norms have to be taken into account to achieve the required CE or even FDA certification. Our design, development and verification processes according to GAMP fulfil these guidelines.
Component procurement, risk management and documentation for medical application are further mandatory tasks, we support our customers in.