To bring safe and effective medical devices to the people in need, compliance with the legislation and regulations relevant to medical devices is of great essence.
Through my training courses I help you discover and experience how the MDR and ISO14155 work within the clinical research with medical devices, and how you can translate this into your daily practice. In small groups, I share my knowledge and experience with the help of practical cases.
As a consultant, I can help you get customized answers to specific issues relevant in your situation. With a risk-based approach, a keen eye on quality and compliance and by safeguarding the rights and wellbeing of the patients.
Or I can intensively support and supervise the implementation process of the MDR and/or ISO14155 into the clinical research with medical devices.
Company’s Keywords:
compliance, csm, medical devices, inspiring, motivating, iso14155, training, quality, clinical research, stakeholder engagement, ichgcp, mdr, consultancy, cra
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