Quality management is more than just an ISO standard or a manual. It is the correct process analysis as well as the definition of the goals and the strategic direction of the company and their implementation. QM is closely related to corporate strategy, corporate orientation and business success. Often there is a blindness in management to the needs of the company and its employees and the right time to make a decision.
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Medical device approvalThe approval of medical devices in Europe according to EU MDR 2017/745 or other regulations, e.g. USA according to 21 CFR 820, is a complex Read more
Quality managementEN ISO 13485 – Quality management for medical devices Quality management is more than just an ISO standard or a manual. It is the right Read more
Risk managementEN ISO 14971 – Risk management for medical devices Risk management covers the entire life cycle of a medical device from the individual phases of Read more
Conformity assessment for medical devicesMedical devices must undergo a conformity assessment in the EU, EEA and Switzerland in accordance with EU MDR 2017/745. This assessment must demonstrate that the Read more
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