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

► Webpage: 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: / natasha-bankowski-0971...
■ Kora Healthcare website: www.korahealthcare.com/
■ PMS Guidance for MDR 2017/745: ec.europa.eu/docsroom/documen...
■ The episode on EUDAMED with Richard Houlihan: podcast.easymedicaldevice.com/25
■ TOPRA Symposium 2019: www.topra.org/TOPRA/TOPRA_Mem...
■ The episode with CEO of TOPRA on Networking at events: podcast.easymedicaldevice.com/39
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Twitter: / elazzouzim
Pinterest: / easymedicaldevice
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#medicaldevice #podcast #easymedicaldevice

[@EasyMedicalDevice]

Thanks Natasha for your valuable info. I hope people will get good value out of it. Don‘t forget to like and share

[@adanmohamedali7328]

Thanks Natsha for your excellence explanation about post-market surveillance or survey

[@khalfiezzedine3452]

Thank you very much Mr Monir El Azzouzi and Ms Natasha for these pertinent information.

[@EasyMedicalDevice]

KHALFI Ezzedine thank you, very appreciated

[@ghulammohyuddinbhatti3292]

Dear Mr Monir El Azzouzi and Natasha thanks for awareness about Post Marketing Surveillance for Medical Devices. I think the Involvement of the personnel comments / complains of Patient / End user / Surgeon (who is implanting and using) Medical Device is necessary for successful Post Marketing Surveillance. How can we involve them, their feed back must be the part of Post Marketing Surveillance.

[@drrutledge1000]

Nice presentation Natasha. Agree, this has become very complicated. Manufacturers will need to evaluate, in detail, all their procedures looking through the lens of input/output triggers between procedures both in terms of (i) process linkages and (ii) data elements. With the additional MDR PMS requirements, one manufacturer found ~70 different triggers that needed to be mapped into their current, out-of-date procedures. A huge amount of work to just get the processes right; implementation is their other challenge. Great job. David R

[@EasyMedicalDevice]

David Rutledge thanks. Really appreciate this feedback and happy that this was helpful.

[@winrichgermann8424]

Many thanks for the overview. For me as a QA/RA consultant the information given is very helpful!

[@vikasghatge154]

If a medical device for the first time going into the market. In that case also post market surveillance is mandatory document to get the medical device compliance CE certification.

[@EasyMedicalDevice]

The PMS plan yes but the report can be issued later.

[@fernandacampestrini89]

Great podcast! Very informative and also highlight the importance of PMS.

[@EasyMedicalDevice]

Thanks Fernanda, really appreciated

[@abdul-wahabraad899]

Very informative discussion. Thanks a lot for sharing these points. looking forward to see more podcasts from you Mr. Monir.

[@EasyMedicalDevice]

Thanks Abd Raad. This one was really great. I hope to do another one with Natasha Bankowski

[@aaravchandraj494]

Many thanks Natasha and Monir for the wonderful info. I am wondering if you could please provide some light on event or incident reporting obligations for a device facility user, such as a hospital or a nursing home, as per the new EU MDR. Thanks again.

[@tristanpayne9447]

Thanks for sharing - helpful pointers!

[@EasyMedicalDevice]

Thanks Tristan. If you have a question that was not answered during the interview, let us know. Happy to help you.

[@davidday2756]

Excellent discussion, very informative.
We have been complying with the MEDDEV and performing an annual PMS meeting over the last few years, with one SOP. I envisage we will have several SOP’s to cover all the Plans, PSUR, etc.
We perform annual Risk Management Reports, can they be repurposed to cover PSUR?
Is there any handy PMS mind map or flow chart that shows inputs/outputs or how it all fits together?

[@htcoztrk]

Hello David. Did you manage to find a relation graphic or flowchart for PMS inputs/outputs demonstrating all the relations and interactions? If you do so, I'll appreciate you can share it with me as I am challenging to put all together in my mind trying to link them together and figure out how to revise SOP or if create different SOPs for each etc.
Thanks in advance.
Best regards,
-Hatice

[@prashantgupta1742]

Hello Monir,
Would it be possible for you to upload the transcripts also here or on your website? It would be easier for us to save time and understand thoroughly.
Thanks

[@EasyMedicalDevice]

I tried to get transcripts on some of the videos. TH-cam is generating automatic captions which is 90% accurate.

[@prasanthkumar9087]

Thanks for the information

[@isomy3122]

Good info.... please do update once any changed.

[@EasyMedicalDevice]

ISO MY thanks. For sure I’ll cover any update

[@jakeshkumar]

U sounds like a echo...try some others mic set or room sound different...,,, Check the lady voice and environment sound is also less....I have seen in every videos..