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. ...
04/16/2026
Regional, traceable, resilient: Why MedTech is reinventing its supply chains. How geopolitical risks, dependence on China, and stricter regulations are fundamentally changing production and supply chain strategies in medical technology. Global MedTech supply chain at its limit. Imagine a medical technology company that previously faced ...
01/20/2026
We are delighted to announce the further strengthening of our team at MEDtech Ingenieur: Since January 15, 2026, Lea Schöppach has been supporting us in the areas of quality management, testing, and production engineering. With her solid training in medical technology and her enthusiasm for quality and technical precision, she brings valuable expertise to the team. ...
11/13/2025
In our globalized world, relocating medical technology manufacturing to the Far East seems attractive at first glance: large production capacities and low prices. For many years, offshoring worked exceptionally well, but recently... ...
11/04/2025
How to check your production documentation for audit readiness: Once production starts, it's too late for uncertainties in the documentation. A missing test report, an unclear work instruction, or an incomplete FMEA – and the audit or series release is already on hold. ...
09/25/2025
May I introduce you? This is EDA – our owl for electrodermal activity. This is EDA, our little owl with a special talent. EDA can measure electrodermal activity (EDA for short) – it precisely and reliably detects even the slightest changes in skin conductance. ...
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