Quality Management for Medical Technology

Once again, we are certified according to ISO 13485. Our quality management meets all of the strict requirements for the development and production of custom medical devices.

Hoffmann + Krippner Logo mit ISO 13485 Certified Stempel

For many years, we have been supplying customers in the medical industry with operating units and components such as keyboards, input devices, sensors and touchscreens. We offer support during the development if needed.

Since 2010, we have been certified according to ISO 13485. In 2018, we implemented the conversion to EN ISO 13485:2016. Compared to ISO 9001, the EN ISO 13485 certification primarily demands an extended risk management and documentation management.

Through close communication with the customer starting during the offer phase, we determine custom requirements and implement them systematically throughout the project. This ensures smooth implementation for series production.

The certification according to EN ISO 13485:2016 ensures our customers that the basic understanding, the necessary tools, methods and standardized processes are anchored within the company. The language, standard terms and requirements are familiar territory for us. We also create significant added value to our customers due to potentially reduced monitoring efforts.

 

Our current certificate can be accessed under downloads: Certificate ISO 13485

 

You have not found the perfect partner for the development and production of a custom control unit for your medical device? We are happy o help! Contact us at +49 6281 52 00-0 or send us an email at info@tastatur.de