Easy Medical Device
EasyMedicalDevice.com is a consulting agency to help you navigate on the Medical Device world by providing information on the Quality, Regulatory Affairs, Compliance, and Innovation area. I'll try to make it understandable so it's easy for you to implement it.
Medical Devices Regulation and technology is changing so fast. 3D printing, Medical Device mobile application. All this needs to be understood and provided with care to the patients. Each country is implementing its own regulation which can be difficult for any company to manage. The analyzes provided on this blog will help you avoid mistakes and be Right the First Time.
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Easy Medical Device
How is a Notified Body Designated? Thomas Lommatzsch from AFNOR Certification will explain to us the journey and also how you can become a Notified Body Auditor.
https://youtu.be/D3FuAAhEr7Q
#medicaldevice #easymedicaldevice #regulatoryaffairs
7 months ago | [YT] | 1
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Easy Medical Device
Join the first Medical Device Live Expert session this June 21st 2024 on Linkedin, Youtube and X.
youtube.com/live/Chbm5Wh-8nY
#medicaldevice #regulatoryaffairs #easymedicaldevice
7 months ago | [YT] | 1
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Easy Medical Device
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In this podcast episode, Heena Thakkar from Alceon Medtech Consulting will help us understand more about the Cleaning Validation for the Surgical Instruments process.
We will try to answer questions like "How do we select a Worst-case device?" or "What are the parameters to confirm?"
So don't miss this episode if you are looking for the best strategy to validate your Medical Devices that need cleaning.
podcast.easymedicaldevice.com/288-2/
#medicaldevice #easymedicaldevice #regulatoryaffairs
7 months ago | [YT] | 0
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Easy Medical Device
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podcast.easymedicaldevice.com/286-2/
#medicaldevice #easymedicaldevice #regulatoryaffairs
7 months ago | [YT] | 1
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Easy Medical Device
What is the Impact of AI ACT on Medical Devices? with Erik Vollebregt
Check the latest Artificial Intelligence update
podcast.easymedicaldevice.com/280-2/
#medicaldevices #easymedicaldevice #regulatoryaffairs
9 months ago | [YT] | 3
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Easy Medical Device
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This week we will have a discussion with Adam Isaacs Rae about Radiation Sterilisation. He will inform us about the different ISO to look at and also how to create a Sterilisation Master File.
If you are also using another sterilisation that Radiation, you may adapt the ISO but the Sterilisation Master File principle would be still valid.
podcast.easymedicaldevice.com/279-2/
9 months ago | [YT] | 1
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Easy Medical Device
Your Regulatory Update for March 2024 is here. Check this out.
This month here is your Regulatory Update.
πΈEU proposal to prevent shortage
πΈNotified Body Survey
πΈSpain: AEMPS consultation
πΈEURL Second Call
πΈTEAM-NB Position Paper
πΈEMDN Proposal
πΈDoes your product qualify for CECP
πΈTraining Green Belt EU MDR March 2024
πΈTEAM-NB Training
πΈPackaging and IFU creation
πΈFDA Fraudulent Lab
πΈCanada Consultation on Significant Changes
πΈMexico to Strengthen the Medical Device Industry
πΈSFDA Harmonized Standards:
πΈQatar Telemedicine
πΈTGA SOPP requirements
πΈTGA Essential Principles
πΈTGA Transition to EU MDR cases:
πΈPODCAST Nostalgia
podcast.easymedicaldevice.com/medical-device-news-β¦
#medicaldevice #easymedicaldevice #regulatoryaffairs
10 months ago | [YT] | 3
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Easy Medical Device
New EU Proposal on Shortage of Medical Devices, IVDR transition, and EUDAMED phase out.
podcast.easymedicaldevice.com/273-3/
#medicaldevice #regulatoryaffairs #easymedicaldevice
10 months ago | [YT] | 0
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Easy Medical Device
PODCAST RELEASE
Discover this crazy information. There is a discussion ongoing to have the gas EtO as a Medical Device under EU MDR.
I couldn't believe it when Christina Ziegenberg from BVMed told me. So we made a podcast to inform you of the situation and if this would affect your medical device.
podcast.easymedicaldevice.com/272-2/
#medicaldevices #easymedicaldevice #regulatoryaffairs
11 months ago | [YT] | 1
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Easy Medical Device
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 donβt 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
podcast.easymedicaldevice.com/241-2/
#medicaldevices #easymedicaldevice #regulatoryaffairs #eqms
1 year ago | [YT] | 0
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