How to be MDSAP certified for your Medical Device?
Within this episode, I will explain to you how you can be MDSAP certified for your Medical Devices. The agenda for this episode is the following:
-
What is MDSAP?
-
Which countries are included in MDSAP?
-
Standards and legislation requirements
-
How to integrate MDSAP into your QMS?
-
Who can audit you for MDSAP?
-
How to verify that you are MDSAP-ready?
Don’t hesitate to check the links below to find more resources to help you.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and notably Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of Medical Device Regulations all over the world. He has now built the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device has become a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links
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MDSAP blog post: https://easymedicaldevice.com/mdsap/
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Podcast episode MDSAP Angelina Hakim: https://podcast.easymedicaldevice.com/10/
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FDA MDSAP procedures: https://www.fda.gov/medical-devices/medical-device-single-audit-program-mdsap/mdsap-audit-procedures-and-forms
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Audit Approach document: https://www.fda.gov/media/157947/download
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Shop MDSAP table: https://school.easymedicaldevice.com/product/mdsap-gap-assessment-tool/
-
MDSAP Auditing Organization: https://www.fda.gov/media/155495/download
Within this episode, I will explain to you how you can be MDSAP certified for your Medical Devices. The agenda for this episode is the following:
- What is MDSAP?
- Which countries are included in MDSAP?
- Standards and legislation requirements
- How to integrate MDSAP into your QMS?
- Who can audit you for MDSAP?
- How to verify that you are MDSAP-ready?
Don’t hesitate to check the links below to find more resources to help you.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and notably Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of Medical Device Regulations all over the world. He has now built the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device has become a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links
- MDSAP blog post: https://easymedicaldevice.com/mdsap/
- Podcast episode MDSAP Angelina Hakim: https://podcast.easymedicaldevice.com/10/
- FDA MDSAP procedures: https://www.fda.gov/medical-devices/medical-device-single-audit-program-mdsap/mdsap-audit-procedures-and-forms
- Audit Approach document: https://www.fda.gov/media/157947/download
- Shop MDSAP table: https://school.easymedicaldevice.com/product/mdsap-gap-assessment-tool/
- MDSAP Auditing Organization: https://www.fda.gov/media/155495/download
