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	<title>Medical Device Courses | bpinette | Activity</title>
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				<title>bpinette replied to the topic  &#034;Animal Diversity in Pre-clinical Research&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/27594/</link>
				<pubDate>Thu, 20 Apr 2023 02:43:23 -0400</pubDate>

									<content:encoded><![CDATA[<p>Diversity in clinical trials is as close as we can get to emulating diversity amongst humans. We know that the body does not react the same to drugs or therapies based on ethnic backgrounds and diverse genomes. Diversity in animals&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/pre-clinical-device-development/animal-diversity-in-pre-clinical-research/#post-17870" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bpinette replied to the topic  &#034;Changing Careers&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/27593/</link>
				<pubDate>Thu, 20 Apr 2023 02:17:16 -0400</pubDate>

									<content:encoded><![CDATA[<p>I was in the Navy for 4 years and then pursued my undergrad in Biological Science. I started working in a research and development for 3 years. I changed careers because I was a bit tired of the constant desire&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/introduction-to-medical-device-development/changing-careers/paged/2/#post-17869" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bpinette replied to the topic  &#034;When is giving gifts like the &#034;old days&#034; too much?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/27592/</link>
				<pubDate>Thu, 20 Apr 2023 02:09:26 -0400</pubDate>

									<content:encoded><![CDATA[<p>My company has a very strict policy against offering gifts to clients. It is very important that we are supporting our clients in their needs and not our own. I think times have changed for the better and focus more&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/consultants-and-legal-basics/when-is-giving-gifts-like-the-old-days-too-much/#post-17868" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bpinette replied to the topic  &#034;Organization Types: Which one benefits you?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/27591/</link>
				<pubDate>Thu, 20 Apr 2023 02:03:09 -0400</pubDate>

									<content:encoded><![CDATA[<p>I prefer a functional organization. I personally thrive when I am in my own element and able to consult with others with a similar background. My company takes a team approach to selling products, so I work with other teams&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/organizational-development-in-device-companies/organization-types-which-one-benefits-you/#post-17867" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bpinette replied to the topic  &#034;Forming a Project Team&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/27590/</link>
				<pubDate>Thu, 20 Apr 2023 01:58:37 -0400</pubDate>

									<content:encoded><![CDATA[<p>I work closely with the projects team in my company. I contribute to the team by consulting with the customer in the early phase of the project. I assist in understanding the customers application needs according to their biologic processes&#8230;. &nbsp; <a href="https://medicaldevicecourses.com/forums/organizational-development-in-device-companies/forming-a-project-team/paged/10/#post-17866" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bpinette replied to the topic  &#034;How to run a risk management meeting ?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/27437/</link>
				<pubDate>Thu, 13 Apr 2023 02:57:56 -0400</pubDate>

									<content:encoded><![CDATA[<p>Risk management meetings should be held frequently. As mentioned in the lecture, these meetings start out as brainstorming sessions. I think this is a very productive stance as one needs to be very creative in evaluating the risk that could&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/risk-analysis-for-medical-devices/how-to-run-a-risk-management-meeting/paged/3/#post-17717" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bpinette replied to the topic  &#034;Hazard, Hazardous, Harm&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/27436/</link>
				<pubDate>Thu, 13 Apr 2023 02:46:59 -0400</pubDate>

									<content:encoded><![CDATA[<p>In my profession, I have been in laboratories that are Biosafety level 1, 2 or 3. A BSL2 lab poses a moderate risk to personnel who enter the lab. The type of bacteria or viruses used in this lab are &#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/risk-analysis-for-medical-devices/hazard-hazardous-harm/paged/2/#post-17716" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bpinette replied to the topic  &#034;Risk management and Labels&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/27435/</link>
				<pubDate>Thu, 13 Apr 2023 02:29:52 -0400</pubDate>

									<content:encoded><![CDATA[<p>I think companies complete risk management protocols for the safety of the user, but also as a means to remove liability. If the company does not provide safety instructions are identify the risk , then they are liable for possible&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/risk-analysis-for-medical-devices/risk-management-and-labels/paged/5/#post-17715" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bpinette replied to the topic  &#034;Design control and risk management&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/27320/</link>
				<pubDate>Fri, 07 Apr 2023 02:39:28 -0400</pubDate>

									<content:encoded><![CDATA[<p>Design control helps mitigate risk by establishing a set of quality practices and procedures as it relates to the products design or development. A product that lacks quality protocols can potentially fail to meet its designed potential. The product needs&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/introduction-to-design-controls/design-control-and-risk-management/#post-17612" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bpinette replied to the topic  &#034;Minutes for meetings&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/27319/</link>
				<pubDate>Fri, 07 Apr 2023 02:25:48 -0400</pubDate>

									<content:encoded><![CDATA[<p>Meeting minutes have always been relevant in my line of work. We dont necessarily generate meeting minutes, but we produce action items in response to the meeting. It is very typical for us to have both the meeting minutes and&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/introduction-to-design-controls/minutes-for-meetings/paged/11/#post-17611" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bpinette replied to the topic  &#034;Validation vs Verification&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/27317/</link>
				<pubDate>Fri, 07 Apr 2023 02:01:03 -0400</pubDate>

									<content:encoded><![CDATA[<p>In my experience with working in research development, verification is a tasks carried out to ensure the developed products efficacy is true to what it registered with the EPA. We would perform test such as shelf life verification which would&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/introduction-to-design-controls/validation-vs-verification-2/paged/2/#post-17609" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bpinette replied to the topic  &#034;Clinical trials for Alzheimer’s disease&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/27263/</link>
				<pubDate>Sat, 01 Apr 2023 15:32:14 -0400</pubDate>

									<content:encoded><![CDATA[<p><a href='https://medicaldevicecourses.com/members/jennifer-sackitey/' rel="nofollow ugc">@jennifer-sackitey</a> I too believe that Alzheimer&#8217;s disease is incredibly complex. The disease starts innocuous and hidden in the body. I think if we can identify the cause and the initial impact on the body, then we can develop better therapies&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/clinical-research-basics/clinical-trials-for-alzheimers-disease/#post-17554" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bpinette replied to the topic  &#034;Incentives for Clinical Trial Participants&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/27262/</link>
				<pubDate>Sat, 01 Apr 2023 15:22:15 -0400</pubDate>

									<content:encoded><![CDATA[<p>Clinical trials are very expensive. Any attempt to find new therapies or new drugs is risky to the patient, but if no risk taken then nothing gained. I believe that incentivizing patients to be part of a clinical trial doesnt&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/clinical-research-basics/incentives-for-clinical-trial-participants/paged/2/#post-17553" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bpinette replied to the topic  &#034;Double Blind Vs Single blind Study&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/27261/</link>
				<pubDate>Sat, 01 Apr 2023 15:15:17 -0400</pubDate>

									<content:encoded><![CDATA[<p>I think there is value in a double blinded study as it removes a very human tendency. I think compassion and emotions as a whole can affect clinical research. If the patient and investigator are both in the dark then&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/clinical-research-basics/double-blind-vs-single-blind-study/paged/7/#post-17552" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bpinette replied to the topic  &#034;Advertising&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/27215/</link>
				<pubDate>Sun, 26 Mar 2023 04:45:02 -0400</pubDate>

									<content:encoded><![CDATA[<p>The most memorable advertisement that I observed was a Doritos commercial. In the commercial, a man had a problem with a mouse living in his house. He attempted to lure the mouse out of its hole in the wall many&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/marketing-and-sales/advertising/paged/5/#post-17499" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bpinette replied to the topic  &#034;Qualifications of Sales People&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/27214/</link>
				<pubDate>Sun, 26 Mar 2023 04:37:47 -0400</pubDate>

									<content:encoded><![CDATA[<p>I do not think sales representatives need significant experience in a particular field they are selling in. However, I think ambition and willingness to learn will have a significant impact on their success. I currently work with my company as&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/marketing-and-sales/qualifications-of-sales-people/#post-17498" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bpinette replied to the topic  &#034;Partnership characteristics&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/27212/</link>
				<pubDate>Sun, 26 Mar 2023 04:25:51 -0400</pubDate>

									<content:encoded><![CDATA[<p>Sole proprietorship has higher risk than a partnership, but it also allows for complete control. Complete control of a company negates the formation of a board members and input on decisions for the company by board members or partners. Complete&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/business-101/partnership-characteristics/paged/5/#post-17496" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bpinette replied to the topic  &#034;What are some ways Document Control can improve?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/27088/</link>
				<pubDate>Sat, 18 Mar 2023 02:36:25 -0400</pubDate>

									<content:encoded><![CDATA[<p>Document control has improved as technology has improved. Lab batch records or protocol have been written in simple word documents in the past and now they are generated in software that is layered with a SCADA program. SCADA is Supervisory&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/quality-control-and-quality-assurance/what-are-some-ways-document-control-can-improve/paged/4/#post-17372" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bpinette replied to the topic  &#034;Responses to Public Health Emergencies&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/27087/</link>
				<pubDate>Sat, 18 Mar 2023 02:24:53 -0400</pubDate>

									<content:encoded><![CDATA[<p>The FDA rolled out the COVID-19 vaccines with as much resource information as they could. I think their intentions were misconstrued and muddled as other media outlets began to provide information that was properly validated. I think if the public&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/regulatory-basics-for-medical-devices/responses-to-public-health-emergencies/#post-17371" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bpinette replied to the topic  &#034;FDA Approval During Public Health Emergencies&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/27086/</link>
				<pubDate>Sat, 18 Mar 2023 02:06:00 -0400</pubDate>

									<content:encoded><![CDATA[<p>The FDA using EUA on drugs and vaccines during public crisis is rather controversial. The race for a vaccine during COVID-19 brought about companies using EUA to accommodate the public&#8217;s need for a vaccine. However, the process of creating a&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/regulatory-basics-for-medical-devices/fda-approval-during-public-health-emergencies/#post-17370" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bpinette replied to the topic  &#034;Approaches to Research&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/26970/</link>
				<pubDate>Fri, 10 Mar 2023 00:43:31 -0500</pubDate>

									<content:encoded><![CDATA[<p>In industry, the research is propelled by money, industry needs and societal trends. The industry is susceptible to trends in the market based on needs or wants by the public. The money ultimately follows these trends and a company can&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/pre-clinical-device-development/approaches-to-research/paged/3/#post-17254" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bpinette replied to the topic  &#034;Species in Animal Testing&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/26969/</link>
				<pubDate>Fri, 10 Mar 2023 00:30:51 -0500</pubDate>

									<content:encoded><![CDATA[<p><a href='https://medicaldevicecourses.com/members/sandra-raju/' rel="nofollow ugc">@sandra-raju</a>  I think it is a very difficult discussion, but indeed necessary. We have made extraordinary strides in science and medicine due to animal testing being implemented in research and development. I will not negate the traumatic impact on any&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/pre-clinical-device-development/species-in-animal-testing/#post-17253" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bpinette replied to the topic  &#034;Academia or Industry Preference?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/26893/</link>
				<pubDate>Mon, 06 Mar 2023 00:46:31 -0500</pubDate>

									<content:encoded><![CDATA[<p>I have worked in industry for the past 9 years. My professional titles include technician, assistant research scientist, service engineer and applications engineer. The last title is my current title and I support companies in industry and academia. The needs&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/introduction-to-medical-device-development/academia-or-industry-preference/paged/2/#post-17168" rel="nofollow ugc">Read more&raquo;</a></p>
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				<title>bpinette replied to the topic  &#034;Project Planning: How Much Detail is Enough?&#034; -</title>
				<link>https://medicaldevicecourses.com/activity/p/26890/</link>
				<pubDate>Mon, 06 Mar 2023 00:46:11 -0500</pubDate>

									<content:encoded><![CDATA[<p><a href='https://medicaldevicecourses.com/members/sandra-raju/' rel="nofollow ugc">@sandra-raju</a> I can appreciate your heeded warning. I can agree that too much detail can become detrimental. I think project planning can become hindered when the customer is overly invested. I have supported clients throughout the SIP installation process and&#8230; &nbsp; <a href="https://medicaldevicecourses.com/forums/intro-to-project-management/project-planning-how-much-detail-is-enough/#post-17182" rel="nofollow ugc">Read more&raquo;</a></p>
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