Six steps to ISO 13485:2016 Certification and MDSAP Certification

This webinar explains the six steps to achieve ISO 13485:2016 certification or MDSAP certification:
1. create a quality plan (which you then implement)
2. conduct an internal audit
3. initiate corrective actions
4. conduct a management review
5. Stage 1 certification audit
6. Stage 2 certification audit
The webinar also explains the 9 steps for creating a procedure. This is a process you will repeat for each of the 28 procedures required in ISO 13485:2016. We also explain which procedures you should be implementing first and why. We provide an overview of the design control process and how that integrates with the processes of risk management, usability testing, and software development. There also other links provided in the webinar to additional training resources from Medical Device Academy.

[Cuauhtlatoac]

thank you for posting this free material in YouTube. It is helping me getting prepared for a very important job interview for a Software Validation position in a Medical Device american company. I hope I get the job as I will soon be unemployed due to a workforce reduction in the company I have been working for the last 3.5 years

[abrahamjacobandes]

Very informative Rob! Will definitely watch all of your webinars! Design Planning, CAPAs, Internal Auditing, Management Reviews, and ISO 13485 Fundamentals!

[mahsamatin]

It is my fist ISO certifications and I am pretty much going through the same journey as you, and I can not express my appreciation for what you do here. Thank you!

[yimpeiyi]

Thank you for this! It is so difficult to equip myself with ISO13485 knowledge due to my company's limited budget. This video has been very helpful in sorting out ISO 13485 into bite sized pieces.

[arunasharma]

This is a great video for somebody starting a career in medical device QA/QC field. I look forward to getting empowered by this wonderful youtube production. Thank you.

[luismunoz]

Rob thank you very much for this video! i am currently in Mexico and i will be taking a lot of training as my job is requesting i take all this training but it's a struggle with the language barrier but I'm slowly tackling that issue. thanks again!

[Sshah-pukm]

Thank you for sharing this information. Great presentation. You know the subject well.

[mariohtml]

Thank you so much for your videos rob, you are so professional on your job

[yasamanalizadeh]

Very informative! Thank you! What are other videos you recommend for a biomedical engineer who wants to work in a regulatory affairs specialist role?

[MRTOMBO]

I keep hearing "ISO 1345 Standard". We are talking about ISO 13485, yes?

[SuperLyas]

This is a great presentation and I am using it to prepare for my AQS certified medical certification. One comment about the order of steps 7 and 8- Should you approve your SOP then perform training? Thanks a lot!

[Zack-Black]

First of all thank you for taking the time to make videos like this.
This might be a stupid question but, what is the minimum number of people that you would need for a small shop to become 13485 certified? From what I'm learning I'm thinking its probably 3. Any thoughts on that? Thanks

[Jamesrdc]

S
Hey Rob great video. Can you recommend anybody to develop a 13485. Thank you!!!!

[congratz]

Great video!
PS: Is 13485 pronounced 1345?