Medical Device Courses | kc377 | Activity https://medicaldevicecourses.com/members/kc377/activity/ Activity feed for kc377. Sat, 16 May 2026 05:36:09 -0400 https://buddypress.org/?v= en-US 30 hourly 2 31dc65430f249a5b008c1eb7925f897e kc377 replied to the topic "Written Agreement v/s Verbal Agreement" - https://medicaldevicecourses.com/activity/p/11451/ Wed, 15 May 2019 16:45:05 -0400 Anthony you pose a great question here. I personally don’t think that a witness in court is enough to back up a spoken agreement with confidence. The opposing counsel will try their hardest to discredit the witness on anything so…   Read more»

]]> a405e8492ed32ecdfb3cbd3c5b0df302 kc377 replied to the topic "Alternatives dispute resolution" - https://medicaldevicecourses.com/activity/p/11450/ Wed, 15 May 2019 16:45:04 -0400 Grzegorz Galka I think your example raises a very relevant, interesting real world example to settling disputes outside of a court. I think many companies, and people for that matter, try to get the most out of every situation. The…   Read more»

]]> fb3857d71b8b466929d1e7c12a3662fd kc377 replied to the topic "Anti-kickback & Stark Cases" - https://medicaldevicecourses.com/activity/p/11449/ Wed, 15 May 2019 16:45:04 -0400 The link that hmp42 posted is very interesting and worth the quick read. I think it’s great to know what the acts mean and why they are important, but I think the real world examples of how they were violated…   Read more»

]]> c8bdf021e675870d3623c4614720fcff kc377 replied to the topic "Risk management and Labels" - https://medicaldevicecourses.com/activity/p/11087/ Wed, 15 May 2019 16:39:47 -0400 While yes, everyone should obviously be trained properly ahead of time, this doesn’t mean that mistakes don’t happen. For instance, if for some reason someone grabbed a drug eluting stent that elutes a concentration much too high for the patient…   Read more»

]]> a368b5187c86fc3a6bb6e917797473e6 kc377 replied to the topic "Risk analysis in real company" - https://medicaldevicecourses.com/activity/p/11086/ Wed, 15 May 2019 16:39:46 -0400 I think the major differences in risk management with medical devices and pharmaceuticals comes down to the mode of action. Pharmaceuticals (in many cases) are chemically based and therefore rely on your bodies’ functions to break it down and utilize…   Read more»

]]> b0b19fa166c790fb062d2aa3fee5d480 kc377 replied to the topic "Discussion Topic: Risk Management, Risk Analysis" - https://medicaldevicecourses.com/activity/p/11063/ Wed, 15 May 2019 16:39:34 -0400 The ISO 14971 regulation lays out an entire risk management framework for medical devices. Regardless of what country you are manufacturing your devices in, they all view this ISO guideline as acceptable for risk management processes. There are many topics…   Read more»

]]> 8480405423ba8a7c594520ef77798631 kc377 replied to the topic "Expense of Regulations" - https://medicaldevicecourses.com/activity/p/11062/ Wed, 15 May 2019 16:39:33 -0400 I think the major reason that these Regulatory Agencies make companies pay for the regulations is simply a matter of business. They spend a huge number of man hours to develop all of these regulations that are essentially only to…   Read more»

]]> 88fbd56cbd3d8e644fa7d7264a194b07 kc377 replied to the topic "Design input sources" - https://medicaldevicecourses.com/activity/p/10841/ Wed, 15 May 2019 16:37:04 -0400 Design inputs ensure that your design requirements correspond with the intended use of the device, with a strong focus on the end users needs. After doing some research on design inputs, I’ve found that the inputs are based on the…   Read more»

]]> 182f2d3a13958e585edf6de4c61ca6af kc377 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/953/ Fri, 09 Dec 2016 00:21:03 -0500 Anthony you pose a great question here. I personally don’t think that a witness in court is enough to back up a spoken agreement with confidence. The opposing counsel will try their hardest to discredit the witness on anything so as to prove their statement may not be trust worthy. Even if the witness is completely clean and trustworthy, theres no…[Read more]

]]> 0 51747fa94693352ca63aaa3ee8f61434 kc377 replied to the topic Alternatives dispute resolution in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/952/ Fri, 09 Dec 2016 00:15:39 -0500 Grzegorz Galka I think your example raises a very relevant, interesting real world example to settling disputes outside of a court. I think many companies, and people for that matter, try to get the most out of every situation. The company that sent the part of course was going to try and get as much money out of the mistake as possible, but there…[Read more]

]]> 0 3959554f8d0b2a8697dde24294c4c7b0 kc377 replied to the topic Anti-kickback & Stark Cases in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/951/ Fri, 09 Dec 2016 00:01:50 -0500 The link that hmp42 posted is very interesting and worth the quick read. I think it’s great to know what the acts mean and why they are important, but I think the real world examples of how they were violated further solidify the importance.
In the article hmp42 posted, Health Alliance of Greater Cincinnati and The Christ Hospital in Ohio, were…[Read more]

]]> 0 1684b1b5465cbf7438ef193f306e8931 kc377 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/502/ Wed, 16 Nov 2016 03:11:19 -0500 While yes, everyone should obviously be trained properly ahead of time, this doesn’t mean that mistakes don’t happen. For instance, if for some reason someone grabbed a drug eluting stent that elutes a concentration much too high for the patient on the table, that could be problematic. All of the staff know how to implement the stent, but if that…[Read more]

]]> 0 4f332bfe454c5f9efb42b2eb558f4bca kc377 replied to the topic Risk analysis in real company in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/501/ Wed, 16 Nov 2016 03:07:35 -0500 I think the major differences in risk management with medical devices and pharmaceuticals comes down to the mode of action. Pharmaceuticals (in many cases) are chemically based and therefore rely on your bodies’ functions to break it down and utilize it effectively. There, the efficacy and risk of a drug is based solely on how it interacts with…[Read more]

]]> 0 04fa72c98f60dbf7452379f16570942d kc377 replied to the topic Discussion Topic: Risk Management, Risk Analysis in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/467/ Mon, 14 Nov 2016 20:33:52 -0500 The ISO 14971 regulation lays out an entire risk management framework for medical devices. Regardless of what country you are manufacturing your devices in, they all view this ISO guideline as acceptable for risk management processes. There are many topics covered in this document, but overall I believe it is useful for identifying your…[Read more]

]]> 0 91a3747cb33d56fd415a7e6a8db53f2a kc377 replied to the topic Expense of Regulations in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/466/ Mon, 14 Nov 2016 20:18:28 -0500 I think the major reason that these Regulatory Agencies make companies pay for the regulations is simply a matter of business. They spend a huge number of man hours to develop all of these regulations that are essentially only to be used by other companies, not themselves. If you want to be compliant with a certain agency, it is a smart business…[Read more]

]]> 0 99502afc9896576606f06f0c061aa2c8 kc377 replied to the topic Design input sources in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/163/ Sat, 05 Nov 2016 16:23:59 -0400 Design inputs ensure that your design requirements correspond with the intended use of the device, with a strong focus on the end users needs. After doing some research on design inputs, I’ve found that the inputs are based on the end users needs, but aren’t simply a list of the end users needs. For example, if you are going to be developing a new…[Read more]

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