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. ...
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. ...
07/30/2025
How does the manufacturing of medical devices work? When we think of manufacturing, we often picture machines that automatically load parts or production workers assembling or inspecting components. But to meet the high quality standards required for manufacturing... ...
12/11/2024
We are delighted that MEDtech Ingenieur GmbH successfully passed the MDSAP (Medical Device Single Audit Program) audit by TÜV Süd a few days ago – without any comments or nonconformities! This outstanding result underlines ...
09/12/2024
The fast eat the slow – the importance of rapid prototyping in electronics development. Our assembly machine allows us to assemble smaller batches manually and much faster. The electronics industry is intensely competitive, and one of the most important features of ...
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