MDC Engineers and Manager Regulatory Affairs provide medical-technical and regulatory knowledge. We consult, design and manufacture medical devices, in-vitro-diagnostic and laboratory equipment, which reflect the state-of-the-art and fulfill market-specific regulatory requirements.
Domain | medical-devices-consulting.de |
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Homepage URL | http://www.medical-devices-consulting.de |
Keywords | notification competent authority consulting assessment / evaluation specific function technical documentation (sted-file) design and development guideline instruction for use essential principles recognized standard marketing clinical classification declaration of conformity corrective preventive actions (capa) medical device act product requirements vigilanz system quality-system-regulation post market analysis regulatory affairs risk management safety repres |