Episode 61 – Medical Device Regulatory Update: January 2020
In this episode of the Medical Device made Easy Podcast, we will review all the major updates that happened in the Medical Device world.
I will try to gather the most important information and comment on them for you. This will also provide you the details of what happened on Easy Medical Device.
During this review, we will discuss the Guidances, standards, regulations that were released. We will also talk about the important news announced like Brexit or Switzerland MRA situation.
In the link section, I tried to gather all the sources for the information I provided so you can check that directly.
I am planning some LinkedIn Live. Don’t forget to follow me on LinkedIn (https://linkedin.com/in/melazzouzi) to be able to see when I am going live. I will also provide you the information when this will be planned. Usually on Friday at 3 pm CET.
- MHRA Guidance: Clinical investigation – https://bit.ly/3iBvklQ
- MDCG Guidance: Cybersecurity – https://ec.europa.eu/docsroom/documents/38941
- CND Nomenclature information – https://ec.europa.eu/docsroom/documents/39007?locale=en
- ISO 14971:2019 standard: https://bit.ly/368Xvl0
- Bassil Akra opinion on Switzerland MRA situation: https://www.linkedin.com/pulse/my-personal-view-situation-switzerland-bassil-akra/
- Erik Vollebregt Blog post on Brexit: https://medicaldeviceslegal.com/2020/01/30/brexit-is-a-fact-now-deal-with-it/
- Bassil Akra Video (Linkedin link): https://www.linkedin.com/posts/wei-jiang-phd_tuvsudmdr-bassilakra-inspiretrust-activity-6628288507058106369-UCo3
- Episode 57 – PMCF with Helene Quie: https://podcast.easymedicaldevice.com/57/
- Episode 58 – 510k Registration with Michelle Lott: https://podcast.easymedicaldevice.com/58/
- Episode 59 – QMS compliant to MDR with Stefan Bolleininger: https://podcast.easymedicaldevice.com/59/
- Episode 60 – How to register your Medical Device in Brazil with Tania Aprigliano: https://podcast.easymedicaldevice.com/60/
- Medical Device School episode 4 – How to audit your suppliers? https://podcast.easymedicaldevice.com/mds4/
- Medical Device School episode 5 – Why is it awesome to work in QA RA? https://podcast.easymedicaldevice.com/mds5/