Consulting: External Safety Officer
The German law requires the manufacturer to install a so-called "safety officer". The safety officer shall be able to act independently within the company on safety related aspects. The safety officer must have certain qualifications and experience. These are aspects which may be difficult for some companies to implement effectively.
MDSS is one of the few consultant companies to offer the safety officer as a service. A safety officer must certainly qualify to perform the specific task to associate with the safety officer responsibility. In order to do so the interface to the manufacturer must be well established to fulfill the requirements and to withstand a Competent Authority inspection in your company.
MDSS is one of the few consultant companies to offer the safety officer as a service. A safety officer must certainly qualify to perform the specific task to associate with the safety officer responsibility. In order to do so the interface to the manufacturer must be well established to fulfill the requirements and to withstand a Competent Authority inspection in your company.
The following services are offered:
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Risk Evaluation
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Correspondence with Competent Authorities
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Notifications of incidents and field safety corrective actions (recall)
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Coordination of corrective actions
- Notification of new medical devices
