How to get MDSAP Certified for your Medical Devices?

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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 inside MDSAP?
- Standards and legislation requirements
- How to integrate MDSAP in 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.
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► 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.
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► Links
■ MDSAP blog post: easymedicaldevice.com/mdsap/
■ Podcast episode MDSAP Angelina Hakim: podcast.easymedicaldevice.com...
■ FDA MDSAP procedures: www.fda.gov/medical-devices/m...
■ Audit Approach document: www.fda.gov/media/157947/down...
■ Shop MDSAP table: school.easymedicaldevice.com/...
■ MDSAP Auditing Organization: www.fda.gov/media/155495/down...
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► Social Media to follow
■ Monir El Azzouzi Linkedin: / melazzouzi
■ Twitter: / elazzouzim
■ Pinterest: / easymedicaldevice
■ Instagram: / easymedicaldevice
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#easymedicaldevice #medicaldevice #regulatorycompliance

Опубликовано:

7 авг 2024

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Комментарии : 5

@martens4899 Год назад

Thank you Monir, for the informative video! I work for a european medical device manufacturer that only produces Class I devices. I've looked into getting MDSAP certified as we are already selling on the australian market and are looking into the States and Canada and are ISO 13485 certified. What I found while doing research however is that class I is usually exempt from audits. Is there a benefit for us to get MDSAP certified? MDSAP doesn't affect the process registering to market, correct? Or does it make it any easier?

@EasyMedicalDevice Год назад

Hi Marten, thanks for your message. Class I are usually self certified but the manufacturers need to have a quality management system. It is not mandatory to be certified but recommended. What is important to understand is that MDSAP is used mainly to avoid audits from the different countries, and use this as a single audit. But it is really rare that a country will initiate an audit for a class I device unless there is a problem on the market. So this is really a company strategy. For Canada, MDSAP is mandatory but I need to check if the rules are different for class I.

@martens4899 Год назад

@@EasyMedicalDevice I understand. Just checked the rules and indeed for Canada MDSAP is not mandatory for Class I device manufacturers. Thank you for your reply.