https://medicaldevicecourses.com/members/anhtong/activity/ Activity feed for anhtong. Fri, 24 Apr 2026 22:30:17 -0400 https://buddypress.org/?v= en-US 30 hourly 2 847ae92d330f0847a2446845107f8ff7 https://medicaldevicecourses.com/activity/p/14434/ Wed, 15 May 2019 18:56:55 -0400 The most valuable asset that every business has is its secrets. In this era where your competitor can get your secrets and outsmart you in performance, NDAs come in handy. They provide protection in the event that prospective relationship with…   Read more»

]]> 1ef4bc553980f95ebdaf115010622ce7 https://medicaldevicecourses.com/activity/p/14432/ Wed, 15 May 2019 18:56:54 -0400 This is a good question for discussion, Roberto. I agree with zmh4 that if two people are out to discuss business, then it should only be about business. However, some issues can come up, and an uninvited or invited party…   Read more»

]]> d6284b232145811d8d3b575999dc6524 https://medicaldevicecourses.com/activity/p/14431/ Wed, 15 May 2019 18:56:54 -0400 I agree with cef3 that verbal contracts are difficult to defend in courts in case a dispute comes up between the two parties to an agreement. This, however, does not mean that verbal contracts are not binding. They are binding…   Read more»

]]> 94f84cbf4ce0bb8cd6919bd671db375d https://medicaldevicecourses.com/activity/p/14341/ Wed, 15 May 2019 18:55:17 -0400 I agree with smk45 that matrix organizational structure is the most ideal for collaboration projects. Staffers in a matrix organizational structure report to a product line manager and a functional manager who determines the direction on product offerings and help…   Read more»

]]> c4459406b0a6d7fad8f7cd8c60eb125b https://medicaldevicecourses.com/activity/p/14340/ Wed, 15 May 2019 18:55:16 -0400 Silo mentality refers to a mindset present when sectors or departments are not willing to freely share information with other members in the same organization. It is not a coincidence that most organizations are constantly faced with interdepartmental turf wars….   Read more»

]]> 6995601fb8a2ca0f0db7af78780ea9de https://medicaldevicecourses.com/activity/p/14339/ Wed, 15 May 2019 18:55:16 -0400 I agree with Anthony Monaco that the choice of an organization structures depends on the size of the company. I must also add that the type of structure chosen also depends on the aims and the type of industry that…   Read more»

]]> 770ce54461690598905a51c089e11214 https://medicaldevicecourses.com/activity/p/14165/ Wed, 15 May 2019 18:52:39 -0400 I agree with ds654 that the full project team should be actively involved in the process of risk identification and that every contribution of each member should be well-documented whether other members consider it significant or not. The best way…   Read more»

]]> 2879ceb02bcfabb8604c173178189398 https://medicaldevicecourses.com/activity/p/14164/ Wed, 15 May 2019 18:52:38 -0400 This is a pretty good topic for discussion, sdl3. You see, these regulations are developed by other companies to help others be compliant. They are basically doing a service to others companies by ensuring that they remain compliant. This is…   Read more»

]]> 946a5255d3485943079e187c3d4d29bb https://medicaldevicecourses.com/activity/p/14163/ Wed, 15 May 2019 18:52:38 -0400 I agree with markabdelshahed that a risk management meeting starts with the project manager sending a meeting invitation to all the attendees ahead of time so that they prepare themselves adequately for the meeting. Usually, the attendees would want to…   Read more»

]]> 515c9b1960672385009e7f582bb93bf0 https://medicaldevicecourses.com/activity/p/14062/ Wed, 15 May 2019 18:51:33 -0400 Verification is the process of ensuring that objective evidence are present and that the specific requirements are met. This process is usually done by inspections, tests, and in some instances analysis. I agree with merzkrashed that verification reduces commercial risks,…   Read more»

]]> c577aa888452a423915836c152da7d86 https://medicaldevicecourses.com/activity/p/14061/ Wed, 15 May 2019 18:51:33 -0400 I agree with you that design meetings facilitate communication between the parties involved such as management, design team, and the customer. Although I don’t have experience with design review meetings, I understand, from research, that they are critical for the…   Read more»

]]> 44ec92385987fa9c5279ad58398b15a8 https://medicaldevicecourses.com/activity/p/14060/ Wed, 15 May 2019 18:51:32 -0400 One of the most problems common with design controls is that medical devices companies put emphasis on following the regulation rather than understanding the intent. For instance, some of the regulations are vague and contain scant details about what manufacturers…   Read more»

]]> 2d7f1cfd5e52f3b02ecae11462a67726 https://medicaldevicecourses.com/activity/p/13826/ Wed, 15 May 2019 17:08:34 -0400 I agree that meetings are important, but often many people do not see their importance. Taking minutes in a meeting requires skill, especially since the minute taker has to follow what the people in the meeting are saying and document…   Read more»

]]> 89e74e72c79003c691065ba4516eb0f1 https://medicaldevicecourses.com/activity/p/13825/ Wed, 15 May 2019 17:08:33 -0400 Gantt Charts are useful in this industry, particularly since they describe and monitor all types of projects being carried out. I agree with your bullet points about the factors to put into consideration when preparing Gantt Charts. If those points…   Read more»

]]> c161da11d3de78123b07a98facc8ace9 https://medicaldevicecourses.com/activity/p/13824/ Wed, 15 May 2019 17:08:33 -0400 A Design History File (DHF) is part of a regulation that established new standards for medical devices. In the event of an audit by a regulatory body, you will need to provide information from the DHF. Medical design companies need…   Read more»

]]> c4368f73224b444c244e9e1569bd5331 https://medicaldevicecourses.com/activity/p/13685/ Wed, 15 May 2019 17:07:15 -0400 While obtaining a signature on an informed consent form is crucial, it is just but a step in the process of obtaining informed consent. As such, researchers should not put a lot of focus and emphasis on making the people…   Read more»

]]> b7c81b36e0b4a6cd6ee8322c9de3d1d3 https://medicaldevicecourses.com/activity/p/13684/ Wed, 15 May 2019 17:07:14 -0400 I would opt for the role of a Clinical Research Associate (CRA) if I were to take part in a clinical research. With this role, I would be responsible for running clinical trials so as to test the effectiveness, benefits,…   Read more»

]]> d5292be096b016c0713a75e04f7a3424 https://medicaldevicecourses.com/activity/p/13683/ Wed, 15 May 2019 17:07:14 -0400 I agree with amandaally1029 that the necessity of a clinical background depends on the role that one decides to follow. I would say that roles such as Principal Investigator in clinical research, for instance, requires a clinical background because of…   Read more»

]]> 743446e574a4b43b386a8ff2f2dacf9b https://medicaldevicecourses.com/activity/p/13536/ Wed, 15 May 2019 17:05:51 -0400 A mission statement defines a company, its business culture, brand identity, and what the company currently achieves. A vision statement, on the other hand, is a blueprint for success. This statement should clearly indicate the company’s aspirations and what it…   Read more»

]]> d45a1bc494229d2f32590f0e739f044e https://medicaldevicecourses.com/activity/p/13535/ Wed, 15 May 2019 17:05:50 -0400 The company that I focused on is Medtronic, Inc., a medical technology company. This company specializes in manufacturing, development, and marketing of medical devices as well as services and therapies for use in treating chronic ailments like spinal conditions, heart…   Read more»

]]> 9d51b2c35e18c8bbb3423d374e5dc4b9 https://medicaldevicecourses.com/activity/p/13534/ Wed, 15 May 2019 17:05:50 -0400 I agree that social media is the most commonly used marketing platform today. Participation marketing can happen online and offline through social media, in grocery store lines, on blogs, and at events. At the heart of participation marketing, lies engagement,…   Read more»

]]> e3e2707b95b17bcc170ade9a720c2588 https://medicaldevicecourses.com/activity/p/13412/ Wed, 15 May 2019 17:04:41 -0400 A major merit difference I have noted in public and private Limited Liability companies is the prestige that comes along with bearing a “PLC” at the end of their name Whether deserved or not, having ‘plc’ at the end of…   Read more»

]]> 84b10054bb477586c139a6f49bc13410 https://medicaldevicecourses.com/activity/p/13410/ Wed, 15 May 2019 17:04:40 -0400 Personally, I would love to be a sole proprietor because I make the sole decision and bear all the risk and make all the decisions meaning both the failure and success of the business are in my hands and I…   Read more»

]]> f4d1b8d7e200752afe16945624696eff https://medicaldevicecourses.com/activity/p/13409/ Wed, 15 May 2019 17:04:39 -0400 A sole proprietorship is a business with one owner-employee who holds assets and is directly responsible for all business obligations. He also has sole control over the business. The phrase “passed on” suggests that the owner is transferring his business…   Read more»

]]> 078efece82adf0a150a6028d850bbc84 https://medicaldevicecourses.com/activity/p/13312/ Wed, 15 May 2019 17:03:49 -0400 Harold Dodge, one of the founders of quality management, changed our view on quality with a vital statement: “You cannot inspect quality into the product.”. The only problem with this statement is that it is decades old yet not nearly…   Read more»

]]> c8d552af817d49132ca75ee780443f97 https://medicaldevicecourses.com/activity/p/13311/ Wed, 15 May 2019 17:03:48 -0400 Document control in QA department can be made easier by: Having a Self-hosted DMS which is a good option for small to midsize departments. It helps to reduce administration time, increase productivity and save money and also gives you complete…   Read more»

]]> f1ee58ef24e7c90c75cb77b456b193ed https://medicaldevicecourses.com/activity/p/13308/ Wed, 15 May 2019 17:03:47 -0400 Quality is a customer determination, not an engineer’s determination, not a marketing determination, or a general management determination. It is based upon the customer’s actual experience with the product or service, measured against his/her requirements – stated or unstated, conscious…   Read more»

]]> 84d34f263c0995bfc46c96d34c20a427 https://medicaldevicecourses.com/activity/p/13134/ Wed, 15 May 2019 17:02:17 -0400 Researchers have examined the 113 devices that the FDA recalled between 2005 and 2009 for posing serious health risks, including endangering patients’ lives. Most of the devices – 71 percent – had been approved without undergoing testing in people, the…   Read more»

]]> 0e24550d75fd125da8b4a324ff34780a https://medicaldevicecourses.com/activity/p/13133/ Wed, 15 May 2019 17:02:17 -0400 I Found that: Ascensia Diabetes Care announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the CONTOUR NEXT ONE Blood Glucose Monitoring System (BGMS), marking a key step in making the next-generation system available to people…   Read more»

]]> a3957643dad215a20c3bdb74c003b9af https://medicaldevicecourses.com/activity/p/13131/ Wed, 15 May 2019 17:02:11 -0400 A cigarette is a very dangerous substance and doesn’t warrant approval by the FDA thus makes me wonder about the next subject an E- Cigarette. I really love innovations and always believed that we are not at the end of…   Read more»

]]> a47b69526868019fa36901d21fbe97da https://medicaldevicecourses.com/activity/p/13048/ Wed, 15 May 2019 17:01:31 -0400 I agree with the relationship that you present about the approaches given to industrial and academic research. As you put it, the purposes of the study conducted in the two areas are different. However, I have a feeling that the…   Read more»

]]> 945795b246de6a1279fb5372f1ed1bbe https://medicaldevicecourses.com/activity/p/13046/ Wed, 15 May 2019 17:01:30 -0400 I agree with the fact that research in the industrial sector takes a short time because of availability of resources. However, I would point out that research should take a reasonable period to be completed even if money is available….   Read more»

]]> 388c05accbc5fcd6ccb3d0f197d09df0 https://medicaldevicecourses.com/activity/p/12993/ Wed, 15 May 2019 17:01:04 -0400 Considering the steps and output gotten from both forms of research I prefer the academia to the industry because the academia research is for the sole aim of researching towards solving a problem and as time goes on the academia…   Read more»

]]> 0ed0190d3a52421c43d58878a0a07d74 https://medicaldevicecourses.com/activity/p/12992/ Wed, 15 May 2019 17:01:03 -0400 Conducting a clinical research is very delicate and when compared to some other forms of research it findings impact its research subjects directly. Although I have not been involved in too many clinical researches I read a lot of books…   Read more»

]]> 489373a93679f803ccc34db453de6625 https://medicaldevicecourses.com/activity/p/12989/ Wed, 15 May 2019 17:01:02 -0400 Frankly, I believe that both research ways are beneficial to the body of study but going against popular view I would prefer the Academia form of research where my research findings become useful at the long run or someone else…   Read more»

]]> 54abd373e1f56abffd9a9dd775422ced https://medicaldevicecourses.com/activity/p/12986/ Wed, 15 May 2019 17:01:01 -0400 I have found all the earlier posts informative and very interesting but some other problems associated with failure to establish a robust design control system is that it can: Lead to the development of product which is not “suitable for…   Read more»

]]> a1f2430e3656f07b1340fcef367bc2a1 https://medicaldevicecourses.com/activity/p/12985/ Wed, 15 May 2019 17:01:00 -0400 One field of medical devices I have flair for is the Bio medical engineering field, and to be more specific I would love to specialize on teaching young bio medical engineering intakes on the course. I would really love to…   Read more»

]]> 88aebc86acdb920f913851b7ffee6bb7 https://medicaldevicecourses.com/activity/p/12984/ Wed, 15 May 2019 17:01:00 -0400 The first advice I will give to Bio Medical Engineering students is to never be discouraged. This may or may not end up being a problem for you, but if you end up doing poorly at any point, don’t get…   Read more»

]]> 3c99706b1c1596bdffcec8aba2b6c405 https://medicaldevicecourses.com/activity/p/5484/ Sun, 03 Dec 2017 21:45:15 -0500 The most valuable asset that every business has is its secrets. In this era where your competitor can get your secrets and outsmart you in performance, NDAs come in handy. They provide protection in the event that prospective relationship with another party does not materialize. Before signing an NDA, it is prudent to understand that you are fully…[Read more]

]]> 0 9b712f4c3619dbbca369a3bab7cf47df https://medicaldevicecourses.com/activity/p/5482/ Sun, 03 Dec 2017 21:43:09 -0500 This is a good question for discussion, Roberto. I agree with zmh4 that if two people are out to discuss business, then it should only be about business. However, some issues can come up, and an uninvited or invited party joins the meeting. In the case of a doctor having a meeting with another person and he decides to bring his wife along, there…[Read more]

]]> 0 977a52333d1dab1f8af0af8bdd5a0e09 https://medicaldevicecourses.com/activity/p/5481/ Sun, 03 Dec 2017 21:41:56 -0500 I agree with cef3 that verbal contracts are difficult to defend in courts in case a dispute comes up between the two parties to an agreement. This, however, does not mean that verbal contracts are not binding. They are binding just like written agreements. The only problem is that they are difficult to enforce in a legal dispute, so I am in full…[Read more]

]]> 0 252e704ea444a35517ae3d9ea0dba55a https://medicaldevicecourses.com/activity/p/5383/ Mon, 27 Nov 2017 05:56:58 -0500 I agree with smk45 that matrix organizational structure is the most ideal for collaboration projects. Staffers in a matrix organizational structure report to a product line manager and a functional manager who determines the direction on product offerings and help with skills, review and prioritization of work respectively. In collaborative…[Read more]

]]> 0 6b40f9a7dd95e011dbda153653537882 https://medicaldevicecourses.com/activity/p/5382/ Mon, 27 Nov 2017 05:55:48 -0500 Silo mentality refers to a mindset present when sectors or departments are not willing to freely share information with other members in the same organization. It is not a coincidence that most organizations are constantly faced with interdepartmental turf wars. More often than not, silos come about because of a conflicted leadership team. The…[Read more]

]]> 0 3cef1585489361e8e0a1b9a2190f99d3 https://medicaldevicecourses.com/activity/p/5381/ Mon, 27 Nov 2017 05:54:41 -0500 I agree with Anthony Monaco that the choice of an organization structures depends on the size of the company. I must also add that the type of structure chosen also depends on the aims and the type of industry that an organization operates in. It is important to note that poorly designed organizational structures will often lead to inefficient and…[Read more]

]]> 0 00d9bedaf94d629ad53366c2fa914c49 https://medicaldevicecourses.com/activity/p/5199/ Mon, 20 Nov 2017 01:49:58 -0500 I agree with ds654 that the full project team should be actively involved in the process of risk identification and that every contribution of each member should be well-documented whether other members consider it significant or not. The best way to identify risks is through past experience, and this includes both negative and positive feedback.…[Read more]

]]> 0 c0eccc4dcf4ff7429f19fc218c878f2d https://medicaldevicecourses.com/activity/p/5198/ Mon, 20 Nov 2017 01:48:51 -0500 This is a pretty good topic for discussion, sdl3. You see, these regulations are developed by other companies to help others be compliant. They are basically doing a service to others companies by ensuring that they remain compliant. This is a point that has been brought forth by Katlin and jnm22. The companies that develop these regulations spend…[Read more]

]]> 0 6e1691ce53b2f6327d4231f87a16bd10 https://medicaldevicecourses.com/activity/p/5197/ Mon, 20 Nov 2017 01:48:12 -0500 I agree with markabdelshahed that a risk management meeting starts with the project manager sending a meeting invitation to all the attendees ahead of time so that they prepare themselves adequately for the meeting. Usually, the attendees would want to discuss about a risk, its characteristics, actions that they think can help and those they think…[Read more]

]]> 0 aabc2c320a3f3c3f4511337d560b1256 https://medicaldevicecourses.com/activity/p/5085/ Mon, 13 Nov 2017 04:37:08 -0500 Verification is the process of ensuring that objective evidence are present and that the specific requirements are met. This process is usually done by inspections, tests, and in some instances analysis. I agree with merzkrashed that verification reduces commercial risks, risks to the users, and the costs of meeting the regulatory requirements. To…[Read more]

]]> 0 8c6c4d0fe368810014711cf88f0e1274 https://medicaldevicecourses.com/activity/p/5084/ Mon, 13 Nov 2017 04:36:18 -0500 I agree with you that design meetings facilitate communication between the parties involved such as management, design team, and the customer. Although I don’t have experience with design review meetings, I understand, from research, that they are critical for the members to review their progress and discuss a way forward. When evaluating a d…[Read more]

]]> 0 0c9f5ea436ecdac0579216bf550e6ae9 https://medicaldevicecourses.com/activity/p/5083/ Mon, 13 Nov 2017 04:35:18 -0500 One of the most problems common with design controls is that medical devices companies put emphasis on following the regulation rather than understanding the intent. For instance, some of the regulations are vague and contain scant details about what manufacturers ought to do to meet the requirements. While manufacturers are required to come up…[Read more]

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