Hellow guys, Welcome to my website, and you are watching Best ISO 13485:2016 Starter Video [For Medical Devices]. and this vIdeo is uploaded by Easy Medical Device at 2019-01-07T03:50:22-08:00. We are pramote this video only for entertainment and educational perpose only. So, I hop you like our website.
| Name | Best ISO 13485:2016 Starter Video [For Medical Devices] |
| Video Uploader | Video From Easy Medical Device |
| Upload Date | This Video Uploaded At 07-01-2019 11:50:22 |
| Video Discription | Easy Medical Device - https://easymedicaldevice.com is a blog to learn about the Medical Device Regulations and Standards. Buy ISO 13485 from my affiliate link: https://tinyurl.com/awin-iso-13485-2016 You can also have a look at my podcast: https://podcast.easymedicaldevice.com On this video, I will tell you what is ISO 13485 version 2016 Where does it come from? Who can certify you for this standard? What are in the main chapters? It´s really important for the medical device industry to have a better understanding of this standard as it is one of the famous ones. It was issued in 2016 and the transition period is 3 years. So you should be finished with your transition by March 2019. This standard is also included on the MDSAP program so if you want to sell your product in CANADA, ISO 13485:2016 is an obligation. (Check this article: https://easymedicaldevice.com/mdsap/ and also the video on my channel about MDSAP) Even FDA said that they are now thinking to transition the QSR to the ISO 13485:2016 so this will become a major standard for the Medical Device Community. Let´s see what is included inside. ISO 13485 has 5 chapters that you´ll need to understand: - Chapter 4: Quality Management System - Chapter 5: Management Responsibility - Chapter 6: Resource management - Chapter 7: Production Realization - Chapter 8: Measurement, Analysis, and Improvement If you are interested to know more about ISO 13485, you can also check my article on BEST TIPS FOR ISO 13485:2016 (https://easymedicaldevice.com/faq-iso-13485/) Please provide me your questions that I can include in this article. I will include my answer to it. -------------------------------------------------------------------------------------------- Links from the Video - FAQ 13845:2016 (Provide your questions) - https://easymedicaldevice.com/faq-iso-13485/ - Check for accredited companies for ISO 13485:2016 - https://easymedicaldevice.com/accreditation-certification-body/ - How to prepare for an audit - https://easymedicaldevice.com/medical-device-audit/ - Podcast Episode 5: Medical Device Prediction 2019 - https://podcast.easymedicaldevice.com/5/ - Person Responsible for Regulatory Compliance - https://easymedicaldevice.com/prrc/ - Free Mini-Course MDR 2017/745 - https://easymedicaldevice.com/mdr - ISO 13485:2016 Affiliate link: https://tinyurl.com/awin-iso-13485-2016 ------------------------------------------------------------------------------------------- Social Media to follow Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice ------------------------------------------------------------------------------------------ #medtech #medicaldevice #compliance Link to this Video: https://youtu.be/3i2gYGzopyY |
| Category | Education |
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