Risk Management
At Medalps, we support medical device manufacturers in building and maintaining robust Risk Management systems aligned with EN ISO 14971 and the EU MDR (2017/745).
Our services - tailored to your needs
Whether you need to establish a Risk Management process from scratch, request an external review of your current processes, or resolve non-conformities raised by a Notified Body, Medalps provides tailored support to fit your needs.
We help medical device manufacturers build and maintain Risk Management processes fully aligned with EN ISO 14971 and the EU MDR (2017/745). Our approach is pragmatic and efficient, ensuring compliance while remaining proportionate to your device portfolio.
What we can do for you
Our services include:
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Creation/Review of Risk Management SOP
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Development and update of Risk Management Plans and Reports
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Identification of hazards and assessment of risks, with integration of state of the art knowledge from standards, literature, and clinical data
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Definition and documentation of risk control measures in line with ISO 14971 hierarchy
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Consistency checks across Clinical Evaluation, PMS, and Technical Documentation
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Gap analysis of existing Risk Management files and recommendations for improvement