On 4 February the Gabinete Técnico Farmacéutico M. Camps and consultancy Azierta organise the webinar "Vigilance and post-marketing of medical devices".
This training, which will be held online for registered users -attendance is free of charge, subject to registration- will provide an overview of regulation and the steps to be taken to carry out PS monitoring.
The market surveillance and monitoring are an essential part of the marketing of medical devices.This is a sector in continuous innovation and of great importance in the European and Spanish market.
The webinar will be moderated by:
- Mercè Camps. CEO and founder of the Technical Pharmaceutical Cabinet MCamps
- Olegario Cuevas. Healthcare Business Manager at Azierta
The webinar presentation will be conducted by:
- Silvia de Andrés. Medical Devices Officer
- Alberto Orós. Technical Consultant
Surveillance and marketing of medical devices:
webinar programme
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- Introduction
- Surveillance system
- Incident management
- Security corrective actions (FSCA) and security notices (FSN)
- Trend reporting
- Post-market surveillance system
- Periodic Security Update Report (PSUR)
- Post Market Monitoring Report (PMSR)
- Post-marketing clinical follow-up
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