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29 December 2016

MEDICAL DEVICES REGULATORY ISSUES:

RESPONSIBILITIES OF A CLINICIAN

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Dr. Susanne Ludgate

Dr Susanne Ludgate, Clinical Director of the Medicines and Healthcare products Regulatory Agency, discusses the role of clinicians in the development and regulation of new devices. She briefly covers the regulatory framework in the EU, and covers issues relating to licensing and  regulation of new devices. Post-marketing surveillance and the importance of clinician reporting of incidents is covered with a number of case studies.

Download

Dr. Susanne Ludgate

Dr Susanne Ludgate, Clinical Director of the Medicines and Healthcare products Regulatory Agency, discusses the role of clinicians in the development and regulation of new devices. She briefly covers the regulatory framework in the EU, and covers issues relating to licensing and  regulation of new devices. Post-marketing surveillance and the importance of clinician reporting of incidents is covered with a number of case studies.

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