healthcare projects consulting & management Stein

healthcare projects consulting & management Stein

your partner for medical device registration & compliance

Medical device approval

The 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 management

EN 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 management

EN 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 devices

Medical 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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