Medical Device Courses | sns34 | Activity https://medicaldevicecourses.com/members/sns34/activity/ Activity feed for sns34. Fri, 24 Apr 2026 22:39:12 -0400 https://buddypress.org/?v= en-US 30 hourly 2 f70d393e4b861d593c92c32d3a2f854b sns34 replied to the topic "Unexpected Clinical Study Results" - https://medicaldevicecourses.com/activity/p/12505/ Wed, 15 May 2019 16:56:36 -0400 Clinical trials do have risks and downsides involved, and thus, this can result in a clinical study being shut down. Unscheduled inspection by FDA staff can uncover not-so-good manufacturing practices, such as contaminated drugs or vials that are being used…   Read more»

]]> 85f59df86c2c910b14d84ff02d341a26 sns34 replied to the topic "Types of Clinical Studies" - https://medicaldevicecourses.com/activity/p/12504/ Wed, 15 May 2019 16:56:36 -0400 Recently, I was involved in a single blind user study at work that involved our production parts and an R&D part that will be available on the market within the next year or two. As Dr. Simon mentioned in his…   Read more»

]]> 44b4402c98839597d54ccf0ec9c60350 sns34 replied to the topic "Clinical Study Location/cost vs. results" - https://medicaldevicecourses.com/activity/p/12501/ Wed, 15 May 2019 16:56:34 -0400 The cost of conducting a clinical study has increased over the years, and thus, this rapid increase has led to companies’ growing interest in cost-saving strategies. That being said, I agree with neb2 because manufacturers of medical products have pursued…   Read more»

]]> 7b0dd3c5cad2ad643de2d1b886aa2214 sns34 replied to the topic "Management Responsibility" - https://medicaldevicecourses.com/activity/p/12408/ Wed, 15 May 2019 16:55:44 -0400 Hi Fady! Unfortunately, companies are constantly under budget restrictions, and sometimes this leads to an entire department to go through a hiring freeze or a travel freeze. Although new engineering projects start in R&D and core team leaders need employees…   Read more»

]]> 5b2f9c56c0820e48bee5d009fb02c8c7 sns34 replied to the topic "CAPA" - https://medicaldevicecourses.com/activity/p/12406/ Wed, 15 May 2019 16:55:42 -0400 Hi All, I would also like to agree with all of the responses above. To put it in simpler terms, Corrective Action is based on a nonconformance event that has happened in the past, and Preventative Action is based on…   Read more»

]]> 83f46253e5d22b8de5f7d3ce3b81cfc3 sns34 replied to the topic "Audits" - https://medicaldevicecourses.com/activity/p/12403/ Wed, 15 May 2019 16:55:40 -0400 Great question! Gh56 goes into wonderful detail about the pros and cons of conducting an internal audit and I’m sure all students can agree with his response. From the time that I started working at the medical device company that…   Read more»

]]> 75a660dae93db44e652fe2e7d84987b9 sns34 replied to the topic "Improving GMPs" - https://medicaldevicecourses.com/activity/p/12334/ Wed, 15 May 2019 16:55:03 -0400 GMP is a regulatory framework which ensures that the production, processing, and packaging of medical devices is safe and effective. Companies that produce the devices must have procedures to comply with these regulations. Although I do not know an exact…   Read more»

]]> 9283547730d7e5057d80e51e8c7e8562 sns34 replied to the topic "No GMPs" - https://medicaldevicecourses.com/activity/p/12330/ Wed, 15 May 2019 16:54:56 -0400 I agree with other students’ input in regards to companies choosing to not have GMP. GMPs typically cause companies to invest in a large sum of money, and to go through the hassle of understanding the regulatory system and requirements…   Read more»

]]> c7b0bec59bc4d1910ec207ed8c00df1d sns34 replied to the topic "Discussion Topic: Vagueness of GMP's" - https://medicaldevicecourses.com/activity/p/12327/ Wed, 15 May 2019 16:54:54 -0400 Yes, I do believe that the GMP’s ambiguity does make it a lot more difficult for startup companies that do not have an existing framework of general requirements to follow. The ambiguity allows for debates to arise and it makes…   Read more»

]]> 5114ee8ac87ee07c3b84a676b6cd1bda sns34 replied to the topic "Discussion Topic: Differences between ISO and FDA" - https://medicaldevicecourses.com/activity/p/11982/ Wed, 15 May 2019 16:51:40 -0400 Hi Dr. Simon! The heart of validating a process is ensuring it is installed to specification, while characterized and optimized to be under control and capable of consistently meeting specifications. I believe that both the FDA and ISO still require…   Read more»

]]> aea80cc90a00330036a070b54ac82d7c sns34 replied to the topic "Process Revalidation" - https://medicaldevicecourses.com/activity/p/11979/ Wed, 15 May 2019 16:51:39 -0400 If the equipment gets moved from one location to another, I do not believe that all processes have to be revalidated. The reason the quality team argued that is because if the equipment was assembled in a different location, this…   Read more»

]]> 2f9b90ddd78f4dccce27615bbfeca5f2 sns34 replied to the topic "Holistic Qualification" - https://medicaldevicecourses.com/activity/p/11978/ Wed, 15 May 2019 16:51:38 -0400 Hi Chris! The ideas of the holistic engineer embodies the point of view than an engineer needs to consider the whole system, the body of work that makes a product successful. The engineer participates in each phase of product development…   Read more»

]]> 2ae94a14fffa6ea570034b4882395340 sns34 replied to the topic "Standard Operating Procedures (SOP's)" - https://medicaldevicecourses.com/activity/p/11815/ Wed, 15 May 2019 16:49:59 -0400 Hi Luisa, I certainly think that SOPs should be required during the research phase. SOPs help define the department’s standard practices and daily processes conducted to assure execution of research tasks in accordance with federal guidance. They should contain adequate…   Read more»

]]> 9399009f142ef1b81581f7d56f9c65d3 sns34 replied to the topic "Discussion Topic: ECO's" - https://medicaldevicecourses.com/activity/p/11814/ Wed, 15 May 2019 16:49:59 -0400 Hello! To maintain and increase market share, manufactures often must respond quickly with engineering changes to their products. These changes might be necessary to respond to safety issues, market demand, or FDA requirements ECOs are documents that a company uses…   Read more»

]]> b526786e842caf61e0449888ee527855 sns34 replied to the topic "Discussion Topic: Post-market surveillance" - https://medicaldevicecourses.com/activity/p/11811/ Wed, 15 May 2019 16:49:57 -0400 The FDA uses post-market surveillance to monitor the safety and effectiveness of medical devices once they are on the market. It is a regulatory requirement and a system that provides continuous feedback about the device on the market in order…   Read more»

]]> b1d0c314afd1fc75465ee45457d44117 sns34 replied to the topic "DHF vs. Tech File/Design Dossier" - https://medicaldevicecourses.com/activity/p/11733/ Wed, 15 May 2019 16:49:13 -0400 I believe that the DHF is more useful than the Tech File/Design Dossier. The FDA is highly concerned with a company’s DHF because it involves everything from risk analysis to an end product where product specifications and customer needs are…   Read more»

]]> 83451308131564d1c30f1ec58a576347 sns34 replied to the topic "Discussion Topic: Verification vs. Validation" - https://medicaldevicecourses.com/activity/p/11732/ Wed, 15 May 2019 16:49:12 -0400 Although it is easy to mix up the concepts behind design verification and design validation, both of them consist of different aspects that ultimately combine to form part of the Design Control. Design Verification confirms that the design output meets…   Read more»

]]> 58884cb3e59102f4f28f3e1275c2fef1 sns34 replied to the topic "Discussion Topic: Is the DHF a living document?" - https://medicaldevicecourses.com/activity/p/11727/ Wed, 15 May 2019 16:49:05 -0400 I agree with the students who believe the DHF is a living document. If any change is made to the medical device, the information should be included in the DHF. If a certain part of the device is altered—such as…   Read more»

]]> 48ae688aa017b398ef20c95b7f2a12b7 sns34 replied to the topic "Guidance Documents" - https://medicaldevicecourses.com/activity/p/11634/ Wed, 15 May 2019 16:48:17 -0400 The answer that I am about to state is based on the links Dr. Simon posted on this week’s lecture and my understanding of the documents. The Guideline Documents are not mandatory, but they certainly provide a way to follow…   Read more»

]]> 83ad48e25e3764b53250bb0d1e3b2150 sns34 replied to the topic "Combination Products in EU" - https://medicaldevicecourses.com/activity/p/11631/ Wed, 15 May 2019 16:48:15 -0400 Hi Fady! I do not have experience with filing combination products in the EU. However, in my opinion, it seems like a major hurdle would be choosing a Notified Body that is capable of evaluating combination products and completing paperwork…   Read more»

]]> 1458928c1f13d313eb893b9771b314ea sns34 replied to the topic "Discussion Topic: Easier regulatory in EU?" - https://medicaldevicecourses.com/activity/p/11629/ Wed, 15 May 2019 16:48:14 -0400 After listening to the lecture, it is clear that it is easier to get devices approved in the EU for several reasons. The EU bases their classification on an essential requirements checklist and on risk. In the United States, regulation…   Read more»

]]> 15667a5d6785f89afe296435e0ead372 sns34 replied to the topic "Primary Mode of Action (PMOA)" - https://medicaldevicecourses.com/activity/p/11628/ Wed, 15 May 2019 16:48:14 -0400 I do not have any experience with working with PMOA for a combination device. After doing research on this topic, I have come to the conclusion that if a company cannot identify a PMOA, a Request for Designation can be…   Read more»

]]> abb23d3a41c4e21364d75ea2a3d6e423 sns34 replied to the topic "Multi-Center Clinical Studies" - https://medicaldevicecourses.com/activity/p/11627/ Wed, 15 May 2019 16:48:13 -0400 Hi Fady, You made a very excellent point because there is definitely a greater chance of data distortion if too many centers are present. Variability needs to be controlled and in order to do so, the scope of the study…   Read more»

]]> 37cea4ff55b324ceae82f0abcca7b7ce sns34 replied to the topic "Legal Contracts" - https://medicaldevicecourses.com/activity/p/11624/ Wed, 15 May 2019 16:48:12 -0400 Hi Andrew, Unfortunately, I do not have any experience in this area, but I do agree with Dr. Simon’s lecture on getting in touch directly with the legal department in order to expedite the process of signing contracts. The legal…   Read more»

]]> ef40dbc82a2cb3835dd4516d13113d0a sns34 replied to the topic "Consultants NDAs and CDAs" - https://medicaldevicecourses.com/activity/p/11407/ Wed, 15 May 2019 16:44:43 -0400 I do not have any similar experiences to the one you provided, but I can definitely say that it is an interesting one. The situation does in fact violate the NDA or CDA for multiple reasons. The consultant is outwardly…   Read more»

]]> 863900981a57403d1744f41f5c7db909 sns34 replied to the topic "Written Agreement v/s Verbal Agreement" - https://medicaldevicecourses.com/activity/p/11405/ Wed, 15 May 2019 16:44:38 -0400 As other students mentioned in their posts, a written agreement is considered a legal binding document, and thus, the agreement is essential if the matter gets taken to court because all parts of the legal contract are clearly stated and…   Read more»

]]> 60650570fb3c241e995b9b1df845d7d7 sns34 replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/11399/ Wed, 15 May 2019 16:44:35 -0400 Undoubtedly, this course was incredibly beneficial and a great learning experience. Before enrolling in this course, I did not hear much about the material, and initially expected to learn about the theory behind developing a medical device. Frankly, I was…   Read more»

]]> 8b9cf2902b4dd1acf454a5d0c4b9813a sns34 replied to the topic "Organization types of medical devices?" - https://medicaldevicecourses.com/activity/p/11315/ Wed, 15 May 2019 16:43:51 -0400 I would choose to startup the company with a Matrix organization. This type of structure would be the most beneficial because the project manager himself can choose employees from different departments—those who would be the most qualified for the particular…   Read more»

]]> ae0f3a97bd02d9e0853072529a5b2110 sns34 replied to the topic "Project Management Preferences" - https://medicaldevicecourses.com/activity/p/11314/ Wed, 15 May 2019 16:43:51 -0400 Hello Lamiaa! That is a very interesting question. It would be more challenging for the project manager to work in a Matrix organization. As mentioned in Dr. Simon’s lecture, every member of the staff as two bosses or more, and…   Read more»

]]> f8884175799c883a132616b4e6cd4b9b sns34 replied to the topic "Discussion Topic: Your organizational type" - https://medicaldevicecourses.com/activity/p/11309/ Wed, 15 May 2019 16:43:48 -0400 Currently, I work in a functional organization structure. In the research and development department, engineers are required to work on a certain project without input from the quality engineers until the time comes. When the project is said to be…   Read more»

]]> 91c0ebe3741a9b89afde910c82b8304b sns34 replied to the topic "how far is "As Far As Possible"" - https://medicaldevicecourses.com/activity/p/11186/ Wed, 15 May 2019 16:40:47 -0400 Reducing risks “as far as possible” is definitely a huge challenge for manufactures. I believe that the statement implies that not all of the risks can be reduced 100%, but it should be reduced as much as possible in order…   Read more»

]]> 09c02d2ccf78b3c1308a36d026d20e9b sns34 replied to the topic "Risk Management Mistakes" - https://medicaldevicecourses.com/activity/p/11184/ Wed, 15 May 2019 16:40:44 -0400 Wow, reading this was extremely interesting and a definite eye-opener. It is an interesting discussion. Companies should perform risk assessments throughout the entire lifecycle of the product—even when it is placed on the market. This is a way to ensure…   Read more»

]]> a7f2088801ac425c437fbaa55985420a sns34 replied to the topic "Expense of Regulations" - https://medicaldevicecourses.com/activity/p/11182/ Wed, 15 May 2019 16:40:39 -0400 I agree with other students in regards to offering the company a subscription where they can access a database that supplies access to all of the necessary documents. Employees will continually have access to articles while the company as a…   Read more»

]]> e62c6f69cc013d3645ec08c9fd0888cb sns34 replied to the topic "Important Part of DDP" - https://medicaldevicecourses.com/activity/p/11037/ Wed, 15 May 2019 16:39:16 -0400 In my opinion, it is very difficult to claim one portion of the DDP as the “most important.” However, if I had to choose a certain aspect that is important in the plan, the scope management plan stands out immensely….   Read more»

]]> 38cfe55fb3e5c8dfc4eecd24a8dfe2da sns34 replied to the topic "Minutes for meetings" - https://medicaldevicecourses.com/activity/p/11032/ Wed, 15 May 2019 16:39:14 -0400 The last thing a manager or an employee wants to do at a meeting is to take the minutes. However, it is an extremely important and necessary task for multiple reasons. A person’s memory is unreliable and it is useful…   Read more»

]]> 9deb379ba4a398cbd990040012276d1f sns34 replied to the topic "Design Transfer and Challenges" - https://medicaldevicecourses.com/activity/p/11027/ Wed, 15 May 2019 16:39:12 -0400 Out of all of the stages that a company’s product goes through, design transfer is the most important. In this stage, the design of the product is introduced to production and requires a full evaluation of the product’s design documentation,…   Read more»

]]> 750c19bae59ffd6f29bd3db3532fd6c9 sns34 replied to the topic "What are Design Controls?" - https://medicaldevicecourses.com/activity/p/10907/ Wed, 15 May 2019 16:37:47 -0400 Safety is a key factor when designing and developing a medical device. Regulatory bodies, such as the FDA, wants assurance that the medical device is safe before bringing the product to the market. Thus, the essence of Design Controls is…   Read more»

]]> 7a21e21583638bf67589fb8969bdeadf sns34 replied to the topic Unexpected Clinical Study Results in the forum Clinical Trials for Medical Devices https://medicaldevicecourses.com/activity/p/2405/ Sun, 23 Apr 2017 23:52:25 -0400 Clinical trials do have risks and downsides involved, and thus, this can result in a clinical study being shut down. Unscheduled inspection by FDA staff can uncover not-so-good manufacturing practices, such as contaminated drugs or vials that are being used during the studies. Thus, risks of contaminating materials intended for use in patients can…[Read more]

]]> 0 26394ffbf91bbe8d309d36e2a26d9094 sns34 replied to the topic Types of Clinical Studies in the forum Clinical Trials for Medical Devices https://medicaldevicecourses.com/activity/p/2404/ Sun, 23 Apr 2017 23:36:23 -0400 Recently, I was involved in a single blind user study at work that involved our production parts and an R&D part that will be available on the market within the next year or two. As Dr. Simon mentioned in his lecture, the study involved a concealed identity of a product—in this case it was 3 prototypes of the new product—and a known identity of…[Read more]

]]> 0 0605b3bf4c413f5c3001c91247db1827 sns34 replied to the topic Clinical Study Location/cost vs. results in the forum Clinical Trials for Medical Devices https://medicaldevicecourses.com/activity/p/2401/ Sun, 23 Apr 2017 23:19:06 -0400 The cost of conducting a clinical study has increased over the years, and thus, this rapid increase has led to companies’ growing interest in cost-saving strategies. That being said, I agree with neb2 because manufacturers of medical products have pursued a number of options to reduce cost, including the use of data from sites outside of the US. D…[Read more]

]]> 0 dff4d00a709a4c302c45baa7b5698f81 sns34 replied to the topic Management Responsibility in the forum Quality Systems Management https://medicaldevicecourses.com/activity/p/2276/ Sun, 16 Apr 2017 18:28:46 -0400 Hi Fady!

Unfortunately, companies are constantly under budget restrictions, and sometimes this leads to an entire department to go through a hiring freeze or a travel freeze. Although new engineering projects start in R&D and core team leaders need employees to take on the workload, the managers of the R&D department do not allow them to hire new…[Read more]

]]> 0 a61544873e98be354e2a0513624d9016 sns34 replied to the topic CAPA in the forum Quality Systems Management https://medicaldevicecourses.com/activity/p/2274/ Sun, 16 Apr 2017 18:02:58 -0400 Hi All,

I would also like to agree with all of the responses above. To put it in simpler terms, Corrective Action is based on a nonconformance event that has happened in the past, and Preventative Action is based on preventing a nonconformance event in the future. Thus, if you both the two together, CAPA is an integral part of a continuous…[Read more]

]]> 0 286d7f6f4c7b2445046dc4b75398c88f sns34 replied to the topic Audits in the forum Quality Systems Management https://medicaldevicecourses.com/activity/p/2271/ Sun, 16 Apr 2017 17:41:48 -0400 Great question! Gh56 goes into wonderful detail about the pros and cons of conducting an internal audit and I’m sure all students can agree with his response. From the time that I started working at the medical device company that I am currently employed at, I have been fortunate enough to be a part of two external audits and one internal audit c…[Read more]

]]> 0 fc32c20b6dace5663a8d84311a3eb0b2 sns34 replied to the topic Improving GMPs in the forum Quality Systems Management https://medicaldevicecourses.com/activity/p/2185/ Mon, 10 Apr 2017 00:40:02 -0400 GMP is a regulatory framework which ensures that the production, processing, and packaging of medical devices is safe and effective. Companies that produce the devices must have procedures to comply with these regulations. Although I do not know an exact number to how often companies should improve/update their GMP requirements, I believe that…[Read more]

]]> 0 654a0732d8dc71fc875b262d43300607 sns34 replied to the topic No GMPs in the forum Quality Systems Management https://medicaldevicecourses.com/activity/p/2181/ Sun, 09 Apr 2017 23:44:07 -0400 I agree with other students’ input in regards to companies choosing to not have GMP. GMPs typically cause companies to invest in a large sum of money, and to go through the hassle of understanding the regulatory system and requirements needed to fabricate proper medical devices. However, although there are advantages to not having GMP, there are a…[Read more]

]]> 0 10f289fb24f00d291d60cd2e1c2546cc sns34 replied to the topic Discussion Topic: Vagueness of GMP's in the forum Quality Systems Management https://medicaldevicecourses.com/activity/p/2177/ Sun, 09 Apr 2017 23:00:03 -0400 Yes, I do believe that the GMP’s ambiguity does make it a lot more difficult for startup companies that do not have an existing framework of general requirements to follow. The ambiguity allows for debates to arise and it makes the company question “where do we begin?” Due to the uncertainty, the company would struggle, and ultimately find a way…[Read more]

]]> 0 92076a72c81895438d839404a10c87c0 sns34 replied to the topic Discussion Topic: Differences between ISO and FDA in the forum Process Validation and Process Risk https://medicaldevicecourses.com/activity/p/1728/ Mon, 27 Feb 2017 03:12:58 -0500 Hi Dr. Simon!

The heart of validating a process is ensuring it is installed to specification, while characterized and optimized to be under control and capable of consistently meeting specifications. I believe that both the FDA and ISO still require “full” verification for a process that supposedly did not need validation. While the wording of…[Read more]

]]> 0 07c655245bea507abacb6a292dede49f sns34 replied to the topic Process Revalidation in the forum Process Validation and Process Risk https://medicaldevicecourses.com/activity/p/1725/ Mon, 27 Feb 2017 02:37:32 -0500 If the equipment gets moved from one location to another, I do not believe that all processes have to be revalidated. The reason the quality team argued that is because if the equipment was assembled in a different location, this might lead to error due to improper setup or a setup in a completely different environment (percent humidity,…[Read more]

]]> 0 65c160aa301afa29c67bd783abb5d93c sns34 replied to the topic Holistic Qualification in the forum Process Validation and Process Risk https://medicaldevicecourses.com/activity/p/1724/ Mon, 27 Feb 2017 02:23:29 -0500 Hi Chris!

The ideas of the holistic engineer embodies the point of view than an engineer needs to consider the whole system, the body of work that makes a product successful. The engineer participates in each phase of product development and is explicitly tasked with making a product succeed. Thus, the holistic approach involves product…[Read more]

]]> 0 f505a4016e54ceddccc5a4c6ee5904dc sns34 replied to the topic Standard Operating Procedures (SOP's) in the forum Device Documentation https://medicaldevicecourses.com/activity/p/1518/ Mon, 13 Feb 2017 01:37:06 -0500 Hi Luisa,

I certainly think that SOPs should be required during the research phase. SOPs help define the department’s standard practices and daily processes conducted to assure execution of research tasks in accordance with federal guidance. They should contain adequate detail to clearly guide research staff through a particular procedure and t…[Read more]

]]> 0