What is Post Marketing Surveillance for Medical Devices? (MDR 2017/745)

► Webpage: https://podcast.easymedicaldevice.com/41

Her nickname is the PMS Queen as she can tell you all you need to know about Post Marketing Surveillance. Natasha Bankowski, Head Regulatory affairs and Pharmacovigilance at Kora Healthcare will really deliver you a masterclass on this episode of the Medical Device made Easy Podcast.

Her advice on this topic is really important as Post Marketing Surveillance is changing a lot with the new Medical Device Regulation MDR 2017/745. There are now some PMS Report, PSUR, PMCF, and EUDAMED that also enters the game.

One important take from this episode is to see the PMS as process connected inside all you Quality Management System and not only as a separated tool. It collects data from so many processes that it is really important to be careful when you are building that for your organization.

► Who is Natasha Bankowski?
Natasha has experience working in both the Pharmaceutical and Medical Device Industry for over 12 years. She has worked across multiple areas including Quality Management, Regulatory Affairs, Medical Affairs, Pharmacovigilance, and R&D.

She has managed the Global Regulatory Affairs, Pharmacovigilance, and Medical Affairs Departments and has being successful in building the global footpath with registrations in over 150 countries.

She is currently working as the Head of Regulatory Affairs and Pharmacovigilance at Kora Healthcare in both the pharma and medical device space. She also lectures part-time in both Regulatory Affairs and Vigilance.

► Links

■ Natasha Bankowski Linkedin: https://www.linkedin.com/in/natasha-bankowski-0971ba28/
■ Kora Healthcare website: http://www.korahealthcare.com/
■ PMS Guidance for MDR 2017/745: https://ec.europa.eu/docsroom/documents/36292
■ The episode on EUDAMED with Richard Houlihan: https://podcast.easymedicaldevice.com/25
■ TOPRA Symposium 2019: https://www.topra.org/TOPRA/TOPRA_Member/Symposium_2019/TOPRA_Annual_Symposium.aspx
■ The episode with CEO of TOPRA on Networking at events: https://podcast.easymedicaldevice.com/39

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Видео What is Post Marketing Surveillance for Medical Devices? (MDR 2017/745) канала Easy Medical Device