Are you active in the medical device sector and do you strive for top quality quality management? Then you need to know something about ISO 13485! Let's take a look at the essential documentation requirements to help you stay compliant and deliver safe, high-quality products.

Quality policies and objectives: Set clear quality goals and commitments. Your roadmap to excellence!
Quality Manual: The ultimate guide to the scope, procedures and interactions of your quality management system.
Device files: Keep detailed records for each device type: description, specifications, manufacturing processes, and more.
Document management: keep documents up-to-date and accessible. Say goodbye to outdated information!
Maintain data: Keep data secure for compliance and smooth operations, so it's available as long as needed.

Adhering to these guidelines is not just about compliance; it's about maintaining high standards and ensuring the safety of your medical equipment. Ready to take your quality game to the next level? Watch now and stay ahead!

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#ISO13485 #Quality Management #Medical Devices #Compliance #Documentation #Care Standards

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► Who is Monir El Azzouzi?

Monir El Azzouzi is a medical device expert, specialized in quality and regulatory matters. After many years working with major healthcare companies, most notably Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand medical device regulations worldwide. He has now founded the consultancy Easy Medical Device GmbH and developed many ways to convey knowledge through videos, podcasts, online courses… His company also acts as an authorized representative for the EU, UK and Switzerland. Easy Medical Device will be a one-stop shop for medical device manufacturers needing quality and regulatory support.

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► Links from the video

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► Social media to follow

■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
■ Twitter: https://twitter.com/elazzouzim
■ Pinterest: https://www.pinterest.com/easymedicaldevice
■ Instagram: https://www.instagram.com/easymedicaldevice

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#easymedicaldevice #medicaldevice #regulatorycompliance

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