If you want to understand the latest update on UKCA then don't miss this talk with Alex Denoon - https://www.linkedin.com/posts/melazzouzi_what-should-you-know-on-ukca-extension-activity-7079382870317752320-Zn9w?utm_source=share&utm_medium=member_desktop
Linkedin
Monir El Azzouzi on LinkedIn: What should you know on UKCA extension
PODCAST RELEASE
The UKCA extension announcement was made and now what should we understand from it? What are the consequences? Should we move to UKCA or wait?…
The UKCA extension announcement was made and now what should we understand from it? What are the consequences? Should we move to UKCA or wait?…
LET'S MEET AGAIN
This year, I am really impatient to attend the Team-PRRC event in Strasbourg.
Check the program here: https://www.team-prrc.eu/page/1111392-presentation?messageError%5B%5D=Vous+n%27avez+pas+le+droit+d%E2%80%99acc%C3%A9der+%C3%A0+cette+page.
This will happen November 16th -17th and there will be as during the first edition a list of great speakers.
Check below:
Orla Daly
Alexey Shiryaev
Nihal Engin Vrana
Anne-Laure Bailly-Dianteill
Anne-Sophie Grell
Emile U.
Erik Vollebregt
Dr. Volker Lücker
Melissa Finocchio
Nebojsa Serafimovic
#medicaldevices #easymedicaldevice #regulatoryaffairs #prrc #eumdr
This year, I am really impatient to attend the Team-PRRC event in Strasbourg.
Check the program here: https://www.team-prrc.eu/page/1111392-presentation?messageError%5B%5D=Vous+n%27avez+pas+le+droit+d%E2%80%99acc%C3%A9der+%C3%A0+cette+page.
This will happen November 16th -17th and there will be as during the first edition a list of great speakers.
Check below:
Orla Daly
Alexey Shiryaev
Nihal Engin Vrana
Anne-Laure Bailly-Dianteill
Anne-Sophie Grell
Emile U.
Erik Vollebregt
Dr. Volker Lücker
Melissa Finocchio
Nebojsa Serafimovic
#medicaldevices #easymedicaldevice #regulatoryaffairs #prrc #eumdr
Springly
Presentation | TEAM-PRRC
The association - Presentation - Welcome to TEAM-PRRC!...
Check the Medical Device news for July 2023. 30 min to get updated on all what is happening. https://podcast.easymedicaldevice.com/239-2/
Medical Device made Easy Podcast
Medical Device News - July 2023 Regulatory Update
july 2023regulatory update
Annex XVI new timeline https://www.linkedin.com/posts/melazzouzi_eu-mdr-annex-xvi-20231194-update-timeline-activity-7082706906317762560-DNEj?utm_source=share&utm_medium=member_desktop
Linkedin
Monir El Azzouzi on LinkedIn: EU MDR Annex XVI 2023/1194 update timeline
Update to Annex XVI timelines after publication of the Commission implementing Regulation 2023/1194
The update was a bit difficult to understand. Not sure why…
The update was a bit difficult to understand. Not sure why…
PODCAST RELEASE
Why should you validate your Quality Management System Software when you work in the Medical Device Field?
Now let's review together the below situation and let me know if this happened to you:
- Auditor: Do you use software to manage your Quality system?
- You: Yes, I use an eQMS?
- Auditor: Do you have a validation report for this software?
- You: But I buy it as is so I am not the manufacturer of it.
- Auditor: Ok, then you don’t have a validation report?
- You: No!!!
- Auditor: Ok, then this is an observation
In this episode with Christophe Girardey from WEGA we will review what is expected from you regarding the validation of such software
https://podcast.easymedicaldevice.com/241-2/
#medicaldevices #easymedicaldevice #regulatoryaffairs #eqms
Why should you validate your Quality Management System Software when you work in the Medical Device Field?
Now let's review together the below situation and let me know if this happened to you:
- Auditor: Do you use software to manage your Quality system?
- You: Yes, I use an eQMS?
- Auditor: Do you have a validation report for this software?
- You: But I buy it as is so I am not the manufacturer of it.
- Auditor: Ok, then you don’t have a validation report?
- You: No!!!
- Auditor: Ok, then this is an observation
In this episode with Christophe Girardey from WEGA we will review what is expected from you regarding the validation of such software
https://podcast.easymedicaldevice.com/241-2/
#medicaldevices #easymedicaldevice #regulatoryaffairs #eqms
Medical Device made Easy Podcast
Validation of Quality Softwares in MedDev
Software validation when used on patient is common and mandatory. But now when we tell you that you should validate also the software you are using to record your documents, CAPAs, or work on the elements related to the product, then this start to be a bit…
Enroll to the e-Training on Vigilance Reporting for EU legislation.
Check the content.
https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
#medicaldevices #easymedicaldevice #regulatoryaffairs
Check the content.
https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
#medicaldevices #easymedicaldevice #regulatoryaffairs
🎙 𝐏𝐎𝐃𝐂𝐀𝐒𝐓 𝐑𝐄𝐋𝐄𝐀𝐒𝐄🎙
In this episode of the podcast, I have invited Enrico Allegra from Testlabs.
He will help us understand how cleaning validation should be done to pass audits.
The topics will be:
💪 What is cleaning validation
💪 What about Microbiology?
💪 Is Material Compatibility important?
💪 Any risk related to Electrical Devices?
💪 What are the issues that raise Notified Bodies?
So if you are really willing to master the art of Cleaning Validation then you should check that now.
LINK: https://podcast.easymedicaldevice.com/247-2/
#medicaldevices #podcast #easymedicaldevice #regulatoryaffairs
In this episode of the podcast, I have invited Enrico Allegra from Testlabs.
He will help us understand how cleaning validation should be done to pass audits.
The topics will be:
💪 What is cleaning validation
💪 What about Microbiology?
💪 Is Material Compatibility important?
💪 Any risk related to Electrical Devices?
💪 What are the issues that raise Notified Bodies?
So if you are really willing to master the art of Cleaning Validation then you should check that now.
LINK: https://podcast.easymedicaldevice.com/247-2/
#medicaldevices #podcast #easymedicaldevice #regulatoryaffairs
Medical Device made Easy Podcast
How to perform your Cleaning Validation in practice? - Medical Device made Easy Podcast
If your Medical Device needs to be cleaned then it means that you need to prove that the cleaning method you propose is working. So how to do that? A laboratory can help for this by testing your method. But what can be some traps to that? Let’s listen to…
Medical Device News October 2023 😝
https://www.linkedin.com/posts/melazzouzi_october-2023-regulatory-update-activity-7115259286691139584-IXqu?utm_source=share&utm_medium=member_ios
https://www.linkedin.com/posts/melazzouzi_october-2023-regulatory-update-activity-7115259286691139584-IXqu?utm_source=share&utm_medium=member_ios
Linkedin
PODCAST RELEASE: Agendy's October 2023 Regulatory Update. | Monir El Azzouzi posted on the topic | LinkedIn
PODCAST RELEASE
Here is your October 2023 Regulatory Update. Agendy below:
EU
- Manual on Borderline and classification for Medical Devices Update
- Q&A on…
Here is your October 2023 Regulatory Update. Agendy below:
EU
- Manual on Borderline and classification for Medical Devices Update
- Q&A on…
Easy Medical Device is introducing you to MedTech Conf a platform to reference your MedTech Events all over the world. If you have an Event to reference then propose it. https://medtechconf.com
eQMS SmartEye https://youtu.be/5kJchdFktL0
YouTube
Top Reasons To Choose Smarteye As Your Electronic Quality Management System!
SmartEye is your eQMS or Electronic Quality Management System to be compliant with ISO 13485, ISO 9001, IEC 62304, ISO 27001, GDPR, IEC 62366, ISO 14971... And also to specific legislation like EU MDR, IVDR, FDA, MDSAP... If you want to manage your Technical…
What is the impact of the AI Act on Medical Devices? Learn more with Erik Vollebregt https://podcast.easymedicaldevice.com/280-2/
Medical Device made Easy Podcast
What is the impact of AI Act on Medical Devices?
AI ACT is also impacting Medical Devices. What are the consequences and how it works together with EU MDR and IVDR?
Do you need to Select and Evaluate your Subcontractor. Then check this episode. https://podcast.easymedicaldevice.com/284-2/
Medical Device made Easy Podcast
How to select and evaluate your Contract Manufacturer?
How to select your Contract Manufacturer for Medical Device companies. Listen to the podcast.
Easy Medical Device pinned «https://www.linkedin.com/events/medicaldeviceliveexpert-17208369164988641280/theater/»
𝐀𝐈 𝐀𝐂𝐓 𝐒𝐔𝐌𝐌𝐈𝐓 2024 - 𝐎𝐜𝐭𝐨𝐛𝐞𝐫 1𝐬𝐭 - 𝐒𝐭𝐫𝐚𝐬𝐛𝐨𝐮𝐫𝐠 𝐅𝐫𝐚𝐧𝐜𝐞 https://medtechconf.com/event/ai-act-summit/
Check this podcast episode on how to use ChatGPT, Bard, Copilot and others for your QA RA work https://podcast.easymedicaldevice.com/300-2/
Medical Device made Easy Podcast
How to use AI GPT for your Quality and Regulatory work?
Podcast: How to use AI GPT for your Quality and Regulatory work? Listen to Martin King’s opinion
⚠️ 𝐁𝐑𝐄𝐀𝐊𝐈𝐍𝐆 𝐍𝐄𝐖𝐒 ⚠️
The Medical Device News for September 2024 is out and here is the agenda
🔸 eIFU - Do you want it for all devices?
🔸MDR Transition
🔸IVDR Common spec
🔸Cybersecurity in the Healthcare
🔸How much cost a Notified Body?
🔸Combined Studies in Switzerland
🔸Is 3D Printing considered Custom made
🔸Training EU MDR
🔸Hot Medtech Event for the next months
🔸Rest of the world news (Australia, USA, Bahrain, Singapore)
🔸 Medical Device Live Experts and Podcast
So I hope you'll like it.
https://podcast.easymedicaldevice.com/301-2/
The Medical Device News for September 2024 is out and here is the agenda
🔸 eIFU - Do you want it for all devices?
🔸MDR Transition
🔸IVDR Common spec
🔸Cybersecurity in the Healthcare
🔸How much cost a Notified Body?
🔸Combined Studies in Switzerland
🔸Is 3D Printing considered Custom made
🔸Training EU MDR
🔸Hot Medtech Event for the next months
🔸Rest of the world news (Australia, USA, Bahrain, Singapore)
🔸 Medical Device Live Experts and Podcast
So I hope you'll like it.
https://podcast.easymedicaldevice.com/301-2/
Medical Device made Easy Podcast
Medical Device News, Septembre 2024 Regulatory Update
EU Switzerland Training Events: ROW Medical Device Live Expert: Podcast