Become more confident in medical device product development. Join 10,000+ of medical device professionals worldwide that take our highly-rated public and customised blended (online + live virtual), classroom and online courses. Our training topics cover risk management, design control, requirements engineering, software development, safety for medical devices, usability engineering, project management, quality management, process validation, and clinical investigation. We have been a member of the CPD Standards Office since 2024, and our training courses are CPDSO-accredited.
Thanks for the forecast! I have a quick question: I have a SafePal wallet with USDT, and I have the seed phrase. (behave today finger ski upon boy assault summer exhaust beauty stereo over). What's the best way to send them to Binance?
Can you give us an example "software compliance tool" that was used to help in IEC62304 compliance? It could be more than one, but I need actual product names
Sir good explanation ...I worked as a ISO COORDINATOR in a Medical Device manufacuring concern in Chennai...More than 10 years of Experience in the same concern. But Now I am 45 years..Can I do this course in online or offline to update myself... Sir i am expecting valuable comment from you...
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?
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?
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
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?
The information in the video is applicable regardless of what area you conduct the FMEA on. For a user interface, you can identify the risk by using a process based on ISO 14971, or you can identify the risks using FMEA AND ISO 14971 risk analysis. Remember, that ISO 14971 requires, among other things, that you include "combination of events", which would not be done if you only approach it using FMEA.
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 RU-vid is blocked from accessing in China. Of course, I will give sources of the original website. Thank you very much!
Thanks @aymemargot4609! You can find the complete course here: medicaldevicehq.com/introduction-to-safety-for-electrical-medical-devices-and-iec-60601-online-course/ This course covers an orientation of the entire IEC 60601 series of standards, how to identify and manage product specific requirements and how this process is integrated with the design control and risk management processes.
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?
Smart glasses or fitness watches that can measure your vital signs etc are not automatically classified as medical devices, unless the manufacturer claims that they can be used for the purpose of diagnosing, treating and interfering with medical decision and treatment.
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?
The short answer is yes. Even though your primary concern should be assessing the performance of the wanted features, I suggest you review the risks associated with the unwanted features. If you are using a SOUP math library, unwanted features will not likely cause any trouble (besides stealing memory). However, if you are using a SOUP with an interface you don't need, you might expose yourself to unwanted cybersecurity risks.
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!
