Відео

Please wear headsets

Very informative, clear explanation!

This is awesome, super informative and a great outline for how to approach Human Factors, Usability and UX research. Will be implementing this methodology!

Thank you Mike and Jon for the informative session and interesting topic.

This was the best ever use of 42 minutes of my life ❤ Absolutely loved this and how it ends, you may have a product that is CE marked/FDA Approved but the QMS is your whole company

Just led a cybersecurity implementaton effort in my last engagement. ALL of this applied and the toughest big was getting the upper level folks to understand it.

I enjoyed the video, thanks for sharing

Thank you! The last slide awesome 😊 as QMS experienced in SW SQA in pharmaceutical, was interested what is going on in medical devices industry.

'Promo SM' 👍

Thanks. This is enlightening! Can you please add to the notes, what were the examples that Jessica was referring to (she couldn’t remember who the presenter was but mentioned had great examples of clear user needs). Thanks much again!

Vascular biometric interesting Tech. Good stuff guy.

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!

FIRST VIEW COMMENT AND LIKE

It seems like this product will not be available for people who already have osteoporosis…even if it’s mild. Can anyone can confirm this?

And now at the end of 2023, still no belt. Possibly doesn’t work? If it does work & becomes available, sure hope it’s more affordable than the Marodyne!

Really Helpful, thanks from Germany !

Thanks for the video...really enjoyed it. It really helped me to think in different directions... Thanks again Jessica and Green light guru

Great talk and Q&A session. Thanks!

I work for a medical device company in the complaint handling unit and I saw someone make a tik tok alleging a defect so I reported it as complaint to my job.

Hi, is clinical trials will be required for breakthrough device procedure

Hi Etienne ! Namaste from INDIA ! I heard every bit of your interview cum discussion on Design Control process for Medical devices with Tom ! I can completely relate with every piece of information and would like to Thank you for coming up with such discussions. Really helps to give a flavor to new and Mid career people in our Medical devices community. I have been part of Medical Devices sector for over a decade now really appreciate the quality of content, questions and specially Tom's response on every query were very relevant !! Keep it up !

Thanks you for that. However, I've had enough of the "Medical Device Theory" and the basics of the Med Device 101. After 25 years in the Medical Device industry and implementing and managing FDA 820 and ISO 13485 QMS's at several small, medium, and large Med Device companies world-wide, I'm only looking for some step-by-step instructions on how to actually use the software that my client has. What button to click on, where is that drop-down menu, how do I enter that piece of data, etc. I know what the software does and why - so, how does it work?

Thanks you for that. However, I've had enough of the "Medical Device Theory". After 25 years in the Medical Device industry and implementing and managing FDA 820 and ISO 13485 QMS at several small, medium, and large Med Device companies world-wide, I'm only looking for some step-by-step instructions on how to actually use the software that my client has. What button to click on, where is that drop-down menu, how do I enter that piece of data, etc. I know what the software does and why - so, how does it work?

Thanks for this informative podcast.

This kind of podcast is indispensable for job interview preparation, so thank you for this!

It's great that people are inventing units to use to increase bone density. I love my Marodyne LiV....I'm a retired pharmacist and I absolutely do NOT want to take Bisphosphonate Medications. Period. The MDs side step the severe side effects that can be caused by taking these meds. I worked in a small community with a large elderly population and I had two patients that suffered from osteonecrosis of the jaw as a result of taking Fosamax. I had a great conversation with Ian Cutts before I ordered the unit (March 2022) and I am so very happy that I did. Anyone in my family, or a friend, can also use the unit as it adjusts to each person's weight automatically. For ten minutes out of my day, every day, in addition to exercise and Vitamins D3 and K2....is do-able, well worth it and no side effects!!😃

why we do not see the belt?

Very helpful! Thank you for the podcast!

Wonderful discussion. Thanks for the great insights

The low intensity vibration trials show positive outcomes on bone growth. The studies were conducted standing on a device that sends vibration through the body. There is no need to lock the knees and 10 minutes is not a long time to be using the device. Whole Body Vibration machines are different - they're mechanical to start with and the scientific studies are varied and mixed. A recent meta analysis of whole body vibration studies concluded that low intensity vibration (30HERTZand <1g force) has been shown to improve bone growth. The clinical trials for the low intensity device was completed using a device you stand on. If this company is going to deliver low intensity vibration using some other means to do it, then I'd be very interested to see the pre and post Dexa scan results of the participants. A belt sounds like a fantastic idea and I really hope it works, but Let's wait for the trials, which I am assuming are being conducted by an impartial body?

Good info guys. Since Covid we see a large influx with IVD analyzers in clinics and physician practices. Do you see this business growing over the years. not necessarily Covid testing but other disease states or ID testing and panels? Or do you think cost/ regulatory vs reimbursement will kill the business model?

Any Violation of Title II of the ADA, or failure to accommodate constitutes a violation of the False Claims Act.

It is NOT true that you are supposed to lock your knees with a Marodyne Liv vibration platform.

Ah, so THIS is where we go to figure out how to fleece Medicare/Medicaid. 👍 As a J.C., I'm a bit non-plussed that her initials are M.M. 😒

This really helps. Thanks & keep it up

What if your product is completely 'back end' with no human operating it. The back end platform that we are developing is SaaS and the only communication is via API. Its system talking to system Do we still need human factors/usability?

Got some good insights from this pod!

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Greenlight Guru has been my bookmarked go to for at least 7yrs now. I live in Remediation, so it's helpful to gut check a simple translation of a vague or prescriptive requirement. This is my first time listening to a podcast and was happy to hear that I'm not the only Design and RM freak! I can trace just about every warning letter back to a lack of design and a complete misunderstanding of risk. Keep doing what you do. You are a positive influence on the Med Dev Industry as a trustworthy resource for us in the field. You help me save lives and I'm grateful for it.

I'm very excited that there are more and more service providers, specifically those companies that provide consulting services for Reg QMS. I've been working on a QMS toolkit that provides consulting firms a formulaic approach to equating people to product. P. S. Greenlight has been my go to guru! Thank you for all you do!

Great guest ! Have part 2 with Mr. Karandeep please!

Biomedical engineer here & find this real interesting as first video from Guru. Thanks

Great interview

Joanne Lebron's knowledge is IMPRESSIVE! I learned a lot from this video! Thank you!

Only 11 views?! People are missing out on great treasures! Thank you for the presentation!!

I really loved this video! It spells out the hidden costs to expect for FDA 483 and Warning Letters. Holeey! I'm excited that Greenlight Guru is 21 CFR Chapter 11 compliant! Trying to keep track of all those electronic records is normally a real time-consuming pain.

Wow! Thank you for this EXCELLENT overview!

This is exciting! Can hardly wait to watch the next videos!

Hi, are you sure GS1 is 'required' for Europe? Will the HIBCC udi system not be accepted in Europe?

Great talk!