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. ...
01/22/2025
We are pleased to welcome Diana Madzar as the new Head of Production for Medical Devices at MEDtech Ingenieur. She took over the management of our production department at the beginning of 2025 and will thus play a key role in the further development of our company. Diana ...
11/29/2021
1, 2 or 3 is not only the question in a well-known quiz show for children on public television, but also for companies that want to market a medical device in the EU. The MDR provides in Article ...
05/08/2020
Application of risk management to medical devices The third edition of ISO 14971 was published in December 2019. This article summarizes the standard and discusses the changes in the standard. Why a new edition? According to ISO, ...
page [tcb_pagination_current_page] of [tcb_pagination_total_pages]