Consultancy: Risk Management
DIN EN ISO 14971 offers a comprehensive basis for risk management processes to medical device manufacturers.
Risk management processes nowadays accompany medical devices from the initial idea of their development right through their production, marketing, use and finally their disposal. Possible risks for the patient, the user or others are in the focus of deliberations.
MDSS' competence team will support you and ease the burden at every stage of this process.
Our team has comprehensive knowledge in product development, manufacture, product management, use of medical devices and market surveillance.
We support your company with the following service packages:
- Development of a tailored risk management procedure including risk management dossier
- risk management plan
- risk analysis
- risk minimization strategies
- risk management report
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Moderation of risk management processes
- identification of risks
- definition of measures
- evaluation of measures
If you would like to receive further information about this service please feel free to use our contact form. We are looking forward to hearing from you.