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
-
-
- 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
-
Latest articles in our blog
Council of Europe approves new medical device regulations
This morning the Council of Europe accepted the new Regulations on Medical Devices and In Vitro Diagnostic Medical Devices. Following the approval by the Council of Europe, they must now be approved by the European Parliament. And once this second body has approved them, the...
Rapex report 3-3-2017: EU recalls moisturiser and lip balm
Last Friday, the Rapex Report 3-3-2017 alert withdrew 58 products from the EU market, a very high number. Of these, four of the items were banned by the Spanish authorities: three toys from China and a tape to hold the...
New AEMPS Quarterly Newsletter on PS and Cosmetics
On 6 February, the Spanish Agency for Medicines and Health Products published its Quarterly Bulletin of the AEMPS on Medical Devices and Cosmetics. This is the issue corresponding to October-December 2016. And it is a summary of the actions of the...