Відео

Thanks for your insightful session. So EMDN is not required for Class III medical devices.

As someone wanting to transition from a rapid-prototype environment to a formal DO-178C environment.. perhaps not for FAA approval, but to develop high quality/safe products for aerospace companies (Lockhead's SEAL Level X, Boeing , DDPMAS etc) , Medical, or Nuclear industries, would love to see a trivial example that goes shows all the steps and outputs. Having a documented process on how code is generated is one thing, but how do you prove safety? Who defines the unit tests? I imagine there are differences between the FAA : DO-178X , DO 331 , ARP4754A , ED-12C FDA : 13485 , ISO14971 , IEC 62304 , SaMD DOE : 414.1x, but what are the typical tools/software , and the typical document/artifacts that are needed in the various stages of the software life cycle? I've see so many options it's a bit overwhelming! Requirement Management - (IBM Ration) DOORS, JAMA, Xebrio, rmtoo florath , doorstop-dev / doorstop , reqview Static Source Code Analysis - Parasoft, PolySpace, CodeSonar, horusec , sonar cloud, veracode PREFast Dynamic Analysis / Modified Condition/Decision Coverage (MC/DC) - VectorCAST, RapiTest Configuration Management / Storage and Version Control System - Git, SourceSafe, Mercurial, MS TFS QA - Helix ALM V&V - VectorCAST, LDRA Testbed Test Automation - Mathworks Simulink DO Qualification Kit Continuous Integration / CD - Continuous Delivery/Deployment What is the general attitude towards open source software (ex. FreeRTOS) and code-generation tools (ex. ST's Cube MX)? How do CPLD and FPGAs fit in to the picture.. since not exactly software, but they are programmable devices written in an programming language like VHDL , (system)verilog?

Very informative ❤

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Wow 😮

Great video, thanks for this. What is your recommendation for documenting deep dependencies for SOUP? For the high level languages, a library could have hundred other libraries as deep dependency, would regulators care for those or could just document the first level dependency and justify why we haven't documented the deeps?

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Where might I find a list of the pure class I devices that don’t need a notified body?

Hi, Sir, I'm freshman in medical devices industry. Your video is very informative and helpful for new learners. Could you please explain what the "design transfer disposable" is? I did not find exact definition for this term. Thank you

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fantastic presentation

Thank you so much for useful explanation and nice tips!

It's an informative session. I have a query regarding RPN, why we are not considering the detection measures in risk evaluation

Great video!

Thank you

This was wonderful and very helpful. Thank you!

Thank you for creating this video. It's helpful.

But how do you get approved for IEC 62304. You have mentioned a few things that must be done regarding version control, documentation and etc. Do you have to provide the source code to whoever is issuing the certificates for them to analyze everything in order to confirm that you are fully compliant?

thank you - great video

What about software FMEA? I don't mean firmware but UI software running in a medical device. Any example?

Thank you

Hi, the link for matrix doesn't seem to work, how can I source this template?

I think your videos are very useful for RA. If you don't mind, I would like to ask your permission to share your videos to the other website in China for the embarrassing reason that UA-cam is blocked from accessing in China. Of course, I will give sources of the original website. Thank you very much!

Could you please send me the template?

Could you please send me the template?

Thank you that was a good video, sorry is there any complete course about the topic?

can a product made up of two 510k cleared medical devices and no biologics or drugs be classified as a combination device?

Best medical devices certification websites for short duration

Thank you so much

Prescription glasses are classified as class I. However, what about glasses that are not prescription glasses and are used solely for cosmetic purposes? I would say they aren’t classified as a medical device. And something I am wondering is what about smart glasses. They would contain software and could show your pulse, etc if they were connected to your Apple Watch. How would you classify those? Are they still class I or are they automatically class IIa? Would you classify them the same whether these are prescription smart glasses or glasses without prescription that are smart glasses too?

Thanks, your presentation was very informative. (Juarez, Mexico)

Does the fact of SOUP or OTS implementing additional functionality, besides the one required for the software under development, i.e. non-specified functionality, be addressed somehow?

Thanks, it's very informative

Brilliant

Thanks Christian for great information!

This was really great! Very informative and short. I have sent it to several colleagues.

Thank you so much for info. I have a query that is single individual user access the data from EUDAMED..? If yes what's the procedure Example : I wanna see some products recall data, can i get that data from EUDAMED..?

Yeah, I know; real late comment: Biggest mistakes is adding numerous of innovative risks and not thinking 1 "are all of these unique risks or can we merge them" 2 "Is this really a probably risk?" Often I see imagninary risks based on really bad behaviour. I mean You can stab someone with a stetoscope. And why add ten different wounds from a sharp edge!

Good presentation, but in my practical experience over many years, there's massive non-conformity in the medical regulatory industry.

Thanks for the great video, would you please help me understand as when would be the deadline/ time for the UDI code for a new medical device to be applied on the packages. The medical device is being manufactured, already certified under MDR by the notified body.

Nice lecture

Informative 👌🏻👍🏻

Great video, thank you so much for sharing!

Very good content! My question is, according to IEC/TR 80002-1 content 'Estimates of probability of a HAZARDOUS SITUATION leading to HARM (P2) generally require clinical knowledge to distinguish between HAZARDOUS SITUATIONS where clinical practice would be likely to prevent HARM, and HAZARDOUS SITUATIONS that would be more likely to cause HARM.' Whether P2 can define a probability table like Po?

which class of device mandates for clinical investigation

Excellent short course

Hi, this is a good presentation. I would like to ask what project management software / app that you recommend to use for easier collaboration between on-site and remote team member? Thank you.

Thanks

Hi Michaela, thank you for the informative video! I would appreciate your advice regarding "summative evaluation" and "usability study". I see that both "summative evaluation" and "usability study" are mentioned in the standard, what are the differences between them? Thanks :) @michaelakauer-franz859