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Best ISO 13485:2016 Starter Video [For Medical Devices]

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Easy Medical Device - easymedicaldevice.com is a blog to learn about the Medical Device Regulations and Standards.
Buy ISO 13485 from my affiliate link: tinyurl.com/awin-iso-13485-2016
You can also have a look at my podcast: 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: 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 (easymedicaldevice.com/faq-iso...)
Please provide me your questions that I can include in this article. I will include my answer to it.
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Links from the Video
- FAQ 13845:2016 (Provide your questions) - easymedicaldevice.com/faq-iso...
- Check for accredited companies for ISO 13485:2016 - easymedicaldevice.com/accredi...
- How to prepare for an audit - easymedicaldevice.com/medical...
- Podcast Episode 5: Medical Device Prediction 2019 - podcast.easymedicaldevice.com/5/
- Person Responsible for Regulatory Compliance - easymedicaldevice.com/prrc/
- Free Mini-Course MDR 2017/745 - easymedicaldevice.com/mdr
- ISO 13485:2016 Affiliate link: tinyurl.com/awin-iso-13485-2016
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Social Media to follow
Linkedin: / melazzouzi
Twitter: / elazzouzim
Pinterest: / easymedicaldevice
Instagram: / easymedicaldevice
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#medtech #medicaldevice #compliance
Link to this Video: • Best ISO 13485:2016 St...

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6 янв 2019

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Комментарии : 48

@EasyMedicalDevice 5 лет назад

ISO 13485:2016 is one of the principle standards to follow if you are a Medical Device Company. Are you already certified? or do you plan to be certified? Let me know on the comments.

@ivanissac858 3 года назад

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@Ivan Issac Instablaster =)

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@Henry Cannon It worked and I now got access to my account again. Im so happy:D Thank you so much you saved my ass!

@henrycannon4194 3 года назад

@Ivan Issac Happy to help xD

@yawagyemangduah1286 Год назад

I am an internal quality auditor at Ghana Cocoa Board where we implement ISO/IEC 17020. Although we are not into medical devices, your video has given me a great understanding of how the ISO 9001 series is applied across several industries.

@EasyMedicalDevice Год назад

Thanks Yaw really appreciated

@stevensevert 5 лет назад

I typically implement and audit against ISO 9001:2015, but I am preparing to implement my first ISO 13485:2016 QMS. I’m excited to work in the medical device industry.

@EasyMedicalDevice 5 лет назад

Steven Severt this will be a great progress and you’ll gain for sure some experience. If you already implemented ISO 9001, you will succeed for this one as you’ll have already the understanding of some requirements. Let me know if you need some advise

@PMpunk 2 года назад

Great video. Can you also do a video description for MDSAP audit?

@discoverafrica7524 2 года назад

Thanks Mounir. Training courses in MDR 2017/745 related to medical devices with this: La Nouvelle Règlementation UE 2017/745 relative aux DM | Udemy

@brahimnouari4477 4 года назад

Thank you so much it was very useful

@EasyMedicalDevice 4 года назад

You’re welcome

@aloysiustzhteo9561 3 года назад

how installation operation and performance qualification related to iso 13485?

@laurenedwards6887 3 года назад

I had completed a course in, Project Management, I am seeking a post relevant to this criteria.

@smithabijoy8605 4 года назад

Hi Monir, Just observed that in this video you have mentioned clause 4 management responsibilities instead of quality management system...explainatio. Is correct .

@simonharrison1874 2 года назад

Helpful video, thanks.

@EasyMedicalDevice 2 года назад

Appreciated

@badarshaikh2768 3 года назад

Hi, I am an Instrumentation engineer working in healthcare field as a service engineer so can I do this course ISO 13485 ?

@vahidahmadian9377 4 года назад

Hello dear Monir. Thank for all your efforts on the Videos. We are small OBL company for dental products in germany. Our company is done through a virtual office. we need ISO 13485 for the products to be able to re export the products. I have seen the other videos about OBL and OEM, but we do not have a place to implement QMS system and to be audited. Is there a chance we can get ISO 13485 based on the OEM companies, like in Korea?

@EasyMedicalDevice 4 года назад

Hi Vahid, thanks for your message. Regarding your question in my opinion this is not possible unless you are considered as the importer but we can explore your situation. Contact me if I can help you.

@rohitparkale8148 2 года назад

Please prepare video on design traceability

@Opt-Shield 3 года назад

We are a small US medical device. If we obtain ISO13485 Certification, can we sell our products in the EU? Do we also have to get CE Mark in order to sell in the EU? In short, to sell medical products in the EU, what is the most cost-effective certification to get for a small company like ours, less than 5 employees. Thank you for your response.

@prabhumuthu5416 3 года назад

Chapter 4- typo errror , it shows Management responsibility and same for Chapter 5. Please check and update.

@beyzacatalay6841 4 года назад

Hi Monir. Thank you for sharing. It is very useful. But I don't understand some of the points because of your pronunciation. Do you have subtitles in English?

@EasyMedicalDevice 4 года назад

Beyza Çatalay sorry for that. My french accent. No english subtitles at that time. Let me knoe what is not cleat and I will try to clarify

@charlesbradshaw2587 5 лет назад

Hello, that is a very good video. Thank you for that. We are a small company that is developing a medical device. How can we get certification to approve that we can implement ISO 13485? Who can give us that certification?

@EasyMedicalDevice 5 лет назад

Hi @charles Bradshaw, on my website I created a 5 steps journey to create and get your Quality Management System certified. This is based on the podcast I have made with Jason Lim. You should follow those 5 steps. In case you need more info, please send me an email. You’ll find the email address on the website easymedicaldevice.com

@ashbird7508 3 года назад

Hi my company stores,package and distribute procedure packs for pathology testing.I would like to find out how to get certification to ISO 13485. the kits are non sterile. The specimens containers withing the procedure packs are CE marked. Please advise how to proceed

@blessyponnachen9528 2 года назад

Please do switch on the english subtitles as a an option in cc

@munasofi5037 4 года назад

Hi Monir, Is ISO 13485 an equivalent to ICH Q10 in Pharmaceutical?

@EasyMedicalDevice 4 года назад

In pharma the standard is called cGMP. This is a free document which explain the requirements for manufacturing of medicine.

@EasyMedicalDevice 4 года назад

Hi Muna, I just checked ICH Q10 and this is only a guideline but not specifically giving you a lot of requirements: Here is the page talking about Good Manufacturing Principles. www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice

@MrKalima1 5 лет назад

Whats's the difference between ISO13485 and ISO9001?

@EasyMedicalDevice 5 лет назад

Hi Arthur, You can have the answer on this section of the article on my blog post. easymedicaldevice.com/faq-iso-13485/#9001 But to make it simple, ISO 13485 is a QMS standard specific for Medical Device companies and ISO 9001 is a QMS for some general companies. There are other business that have some specific standard like Automotive, Aerospace... I hope this helps. Monir

@blessyponnachen3663 2 года назад

You have given chapter 4 as management responsibility which is wrong

@EasyMedicalDevice 2 года назад

Thanks for this feedback. Sorry for this mistake. Chapter 5 is for Management responsibility.

@abdurraheemnaderi4651 5 лет назад

your video is very nice and educational but the background music sucks. It would be best if in your future videos you dont include background music so what you are talking about can easily be understood.

@EasyMedicalDevice 5 лет назад

AbdurRaheem Naderi thanks for your feedback. I will consider that for next videos. Are you in the medical device industry?

@abdurraheemnaderi4651 5 лет назад

@@EasyMedicalDevice I am getting in the field with few of my friends.

@EasyMedicalDevice 5 лет назад

AbdurRaheem Naderi great. I hope the different videos and blog posts will help you succeed. Where are you from?

@annas986 3 года назад

thanks for the video, please stop saying "soooooooooooooooooo" "aaaaaaand"

@EasyMedicalDevice 3 года назад

Hahaha. Thanks. Not easy. These are my first videos. Please look at the latest ones. I cannot promise to not say it again but I hope I feel more confident. lol. Thanks for helping me to improve.