https://medicaldevicecourses.com/members/gfashaw/activity/ Activity feed for gfashaw. Fri, 24 Apr 2026 22:30:17 -0400 https://buddypress.org/?v= en-US 30 hourly 2 cec4fc69a30eb9a0a2c2c2b4e10f5fe3 https://medicaldevicecourses.com/activity/p/22817/ Mon, 28 Jun 2021 03:27:54 -0400 Validation is the process that guarantees the product quality that the end user expects.  The design must provide that expectation with a process that can be consistent with that expectation as well.  The regulatory environment must use its systems to…   Read more»

]]> 2347e766a3853467b2df2637d0638197 https://medicaldevicecourses.com/activity/p/22816/ Mon, 28 Jun 2021 03:01:08 -0400 Medical devices must be safe and reliable.  With data from the FDA that states that “44% of voluntary recalls from October 1983 through September 1989 may have been prevented by adequatedesign controls,” and “The most frequent causes for recalls are…   Read more»

]]> e82cc3adaaf9feb0c5874a9500af5f4d https://medicaldevicecourses.com/activity/p/22814/ Mon, 28 Jun 2021 02:53:44 -0400 As with many things in medicine and healthcare it looks good on paper.  In action is where the ethical dilemmas present themselves.  On one side there is a huge opportunity to advance medicine in real time.  On the other end…   Read more»

]]> 3d793cf1ee68b591a968f5e6f95c66c6 https://medicaldevicecourses.com/activity/p/22813/ Mon, 28 Jun 2021 02:46:44 -0400 Experience is always valuable.  That is even more important in clinical research.  There is huge liabilities that are present when conducting research on human subjects.  I can understand why experience is so important.  My mom recently retired as a clinical…   Read more»

]]> dc2463ecf9a3b2b09a0c092b1fab4154 https://medicaldevicecourses.com/activity/p/22811/ Mon, 28 Jun 2021 02:30:07 -0400 I live in a country where many people believe that we should have the right to choose.  Choose to own a gun, choose to say what we want, choose to vote; the quote life, liberty, and the pursuit of happiness. …   Read more»

]]> 115f5fadeab9e1c17f492f289a8aac00 https://medicaldevicecourses.com/activity/p/22810/ Mon, 28 Jun 2021 02:18:33 -0400 I taught an entrepreneurship class for a summer camp we did for our students.  In that class we watched a video on how Coca Cola was started.  At the time there was differentiation in branding among colas.  Coca Cola became…   Read more»

]]> 80a0d57417a5dc5aa582a9777a32d70a https://medicaldevicecourses.com/activity/p/22809/ Mon, 28 Jun 2021 02:11:28 -0400 @jafar The fact that the fate of the business is not connected to any individual owner upon there death is extremely important.  The flexibility with ownership makes comfort in longevity a lot easier.  I would love to do further research…   Read more»

]]> 2314b2dba09cd290ed071cdbed5c732a https://medicaldevicecourses.com/activity/p/22807/ Mon, 28 Jun 2021 02:06:20 -0400 At this time I would start an LLC.  I would start an LLC because it is cheaper and easier to start.  An LLC will still provide the legal protection that I would need when operating a business.  I would hope…   Read more»

]]> ea30fcafad00529bdbf5ef8af0e34781 https://medicaldevicecourses.com/activity/p/22806/ Mon, 28 Jun 2021 01:51:09 -0400 I have not worked in a regulatory project but I have worked in government inspections and enforcement.  My first experience in the field was in zoning code enforcement.  I was responsible for enforcing the Denver Zoning Code and portions of…   Read more»

]]> 5dde6e3c9c35a3a8fe4db786d1ec560c https://medicaldevicecourses.com/activity/p/22804/ Mon, 28 Jun 2021 01:44:40 -0400 QA/QC in relation to ethics can present interesting dynamics.  I can go back to my college job as a cashier at Home Depot.  We were asked to meet performance measures of timeliness, accuracy, sales, and service.  Specific examples of ethical…   Read more»

]]> ebda2c83853ef240dd4b089e5673a1b4 https://medicaldevicecourses.com/activity/p/22802/ Mon, 28 Jun 2021 01:35:12 -0400 If I was to simplify the difference between quality control and quality assurance, I would say that QA puts systems in place that supports the creation of a quality good or service.  QC refers to working the system to make…   Read more»

]]> 965a74501fd303eb2020738d01c0d675 https://medicaldevicecourses.com/activity/p/22798/ Sun, 27 Jun 2021 23:20:54 -0400 @llefevre This is a very interesting topic.  Companies can’t be innovators and pioneers if they have not mastered the other needs outlined in the pyramid.  It makes me think if that is true.  If we look at many of the…   Read more»

]]> 6993b94d1ee337b6efd74b882e1b02ff https://medicaldevicecourses.com/activity/p/22797/ Sun, 27 Jun 2021 23:13:53 -0400 I have not personally signed a non-compete agreement.  It seems as though in biotech that it would almost be a necessity.  With the success of biotech organizations directly related to innovation, it is absolutely necessary to protect themselves.  Without an…   Read more»

]]> a255bb70185e0508770e602b169d630e https://medicaldevicecourses.com/activity/p/22796/ Sun, 27 Jun 2021 23:08:48 -0400 The type of organization that works best is the one that maximizes management effectiveness.  My preference is a matrix organization.  The matrix organization has a lot of benefits.  I believe it provides a strong team environment where people take on…   Read more»

]]> 54b8ea10c059796f8c6eccf63bae305a https://medicaldevicecourses.com/activity/p/22495/ Mon, 17 May 2021 11:34:10 -0400   If I were involved with a medical device development project, biomaterial selection would be important.  Choosing the right biomaterial is important for project success.  Biomaterial selection involves a number of tests to ensure safety for the end users.  Depending…   Read more»

]]> 8a1db7cd5a670dbeeff687025068cd02 https://medicaldevicecourses.com/activity/p/22494/ Mon, 17 May 2021 11:28:31 -0400 I am on the fence with this topic.  On one hand, animal studies have contributed greatly to the medical innovation.  That innovation has been accomplished in medical device development and novel treatments.  It seems as though the life of humans…   Read more»

]]> 14b443fe3a926d2d872579d93d614dba https://medicaldevicecourses.com/activity/p/22421/ Fri, 07 May 2021 00:47:51 -0400 As I am choosing my career path in Biotechnology, project management is definitely in consideration.  I have also never seen any project manager positions that do not require experience.  The scope of project management is not something that can be…   Read more»

]]> 5cd632e39e7b0446d8d76c6f7828197e https://medicaldevicecourses.com/activity/p/22420/ Fri, 07 May 2021 00:40:47 -0400 @ssbufford Thank you for highlighting the impact the new normal is having inside our hospitals.  As a classroom teacher I feel the impact of the pandemic on my job every day.  Desk shields, masks, disinfectant wipes are part of my…   Read more»

]]> e2febd5a38c224b8e7ec9aeefaf654be https://medicaldevicecourses.com/activity/p/22419/ Fri, 07 May 2021 00:33:59 -0400 COVID-19 has impacted nearly every aspect of life.  It was a global problem that presented problems for most industries.  The medical device industry was impacted greatly.  The pandemic especially highlighted the failures of the medical device supply chain to operate…   Read more»

]]> 91a01f7254638aee7c488e1c4cad211b https://medicaldevicecourses.com/activity/p/22185/ Mon, 19 Apr 2021 03:22:27 -0400 This course is extremely beneficial.  Not only does this course directly translate to all sectors within biotechnology, but it also has immense value across many industries as well.  The knowledge we are receiving are valuable to seemingly any organization.  To…   Read more»

]]> 61b08270d65c4b8fb3ad1702c46ea9e5 https://medicaldevicecourses.com/activity/p/22183/ Mon, 19 Apr 2021 03:17:07 -0400 Planning for unresponsive team members should be included very early.  This can be managed by having a universal data management system that tracks the tasks and work completed by each individual.  This can be supported by a multi-leveled communication strategy. …   Read more»

]]> f4636850c6afeef51fe2f5b04fb62efc https://medicaldevicecourses.com/activity/p/22180/ Mon, 19 Apr 2021 03:05:14 -0400 I believe that verification is extremely important to design control in medical devices.  As user needs are identified, designs for satisfying those needs can begin.  It through the verification process that that quality, safety, and effectiveness can be maximized.  Without…   Read more»

]]> baefcb0deca490f82423d85ff02ca152 https://medicaldevicecourses.com/activity/p/21594/ Mon, 08 Mar 2021 04:26:46 -0500 Every project is a learning the experience.  Nothing ever happens exactly the same.  That is why it is so important for a debrief at the end of every project.  A review of meeting minutes recorded throughout the project, exit interviews,…   Read more»

]]> 186887acb9e589d37901fbee41b9c5c1 https://medicaldevicecourses.com/activity/p/21590/ Mon, 08 Mar 2021 04:20:10 -0500 Working on a project will require high levels of emotional intelligence.  As a 6th grade math teacher, I don’t only teach math content, but integrate social-emotional learning opportunities as well.  Our basic emotions of love, happiness, sadness, anger, and fear…   Read more»

]]> a7ec38d5bcfd82034e6d75f3878ca48b https://medicaldevicecourses.com/activity/p/21582/ Mon, 08 Mar 2021 04:01:25 -0500 I believe that the basic understanding of a well functioning team is the idea of synergy.  Every team member must embrace the idea that the sum, or whole, is greater than each individual part.  A commitment to the projects purpose…   Read more»

]]> ddcd84882f403c7951da5e6f7e061ddd https://medicaldevicecourses.com/activity/p/21483/ Mon, 01 Mar 2021 20:14:19 -0500 0