When requirements start to become fragmented... The larger and more complex a medical device development project becomes, the more information is generated. Requirements are documented in documents, technical decisions are recorded elsewhere, and tests are documented in separate files. ...
09/10/2026
Our production hub in Erlangen is growing for the second time. We've significantly expanded the production area once again. What began as a small in-house manufacturing facility next to our development office has now become an integral part of what we offer our customers. ...
08/13/2026
Traditionally, EMC testing of medical devices focuses on basic safety and essential performance. But what about functions that, while not directly safety-critical, nevertheless play an important role in clinical application? This is precisely where this approach comes in. ...
06/16/2026
The new EU Battery Regulation was adopted in 2023 and is being phased in. Battery Regulation 2023/1542 can have a significant impact on medical technology, particularly on medical device manufacturers. It can lead to a complete redesign of the mechanics and electronics. ...
Why FPGAs in medical devices are increasingly becoming the focus of software audits and how you can avoid regulatory risks early on. When programmable logic suddenly ends up in a software audit, things can quickly become uncomfortable when the auditor asks you: "Where is your ...
05/14/2026
Many medical technology companies face the central challenge of transferring a developed medical device from development to series production – while complying with MDR, ISO 13485, and achieving full audit readiness. This is particularly true for prototype production, small-batch production, and early series production. ...
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