Medical technology

Medical technology accounts for an ever-increasing share of our economy, not only because of rising life expectancy, but also because technological progress is providing more and more opportunities to help individuals.

At the same time, ever higher demands are being placed on design, documentation and risk analysis. On the one hand, this is due to scandals in which products are manufactured and sold that do not fulfil the necessary requirements for safe use, but on the other hand it is also due to the ever-increasing desire for safety.

Medical devices are subject to international regulations that are becoming more and more harmonised, but also impose increasingly stringent requirements. For the European market, these are the Medical Device Directive (MDD) 93/42/EEC, 90/385/EEC for active implantable medical devices (AIMDD) and 98/79/EC for in vitro diagnostics (IVDD).

The Medical Device Directive (93/42/EEC) and the Directive on Active Implantable Medical Devices (90/385/EEC) were replaced by the new Medical Device Regulation (MDR) in 2017, which is currently scheduled to replace the aforementioned directives on 26 May 2021.

The directive for in-vitro diagnostics was also renewed in 2017, and the new directive is due to come into force on 26 May 2022.

In addition to the EU directives, a number of standards must be observed when developing a medical device:

DIN EN ISO 10993-1 (Biologische Beurteilung)
DIN EN ISO 13485 (Quality management)
DIN EN ISO 14155 (Clinical trial)
DIN EN ISO 14971 (Risikomanagement)

Außerdem sind auch produktspezifische Normen zu berücksichtigen.

My offer

Medical technology design

In the design, I limit myself to the mechanical side of the construction. Of course, I can also work together with circuit developers and programmers if necessary.

The design is carried out with SolidWorks.