https://medicaldevicecourses.com/members/asimbana/activity/ Activity feed for asimbana. Fri, 24 Apr 2026 18:53:59 -0400 https://buddypress.org/?v= en-US 30 hourly 2 db799743029ba8943e593cacbf260ebb https://medicaldevicecourses.com/activity/p/15837/ Wed, 15 May 2019 19:14:26 -0400 As the previous commentator mentioned previously, it is difficult to predict adverse effects of a product using collected data from pre-clinical trials. Indeed, pre-clinical trials holds value but it can only be represented to a certain point before reaching into…   Read more»

]]> 1bf599c123bbf1e8a814e6c1dcd7990b https://medicaldevicecourses.com/activity/p/15836/ Wed, 15 May 2019 19:14:26 -0400 During Clinical Trials there is always the potential of risk. such as immediate biasing in the trial groups from either the patients or the actual doctors conducting the tests. Several trial groups are created, a placebo, blind and a controlled…   Read more»

]]> da9f9983f74a9bb8e5e633735e2f729f https://medicaldevicecourses.com/activity/p/15697/ Wed, 15 May 2019 19:12:58 -0400 As mentioned by many above, correction is the actual action to eliminate the nonconformity, on the other hand the corrective action is the process to actively prevent the nonconformity from occurring; which is CAPA. In addition as mentioned, correction is…   Read more»

]]> c10644e49d76e82258f6cbeba1a33ae7 https://medicaldevicecourses.com/activity/p/15696/ Wed, 15 May 2019 19:12:58 -0400 In my experience with nonconformance with one of our products, it was related to an issue that was identified through receiving feedback from our QC team. In addition, this finding matched with the findings discovered from our field technicians that…   Read more»

]]> 196fe7223d82fb20125d549c45c21d18 https://medicaldevicecourses.com/activity/p/15657/ Wed, 15 May 2019 19:12:34 -0400 In my opinion, and as mentioned prior by some of the users, this situation is handled differently case-by-case. There are only certain situations when documents from previous product can be grandfathered into a new product, if and only if, the…   Read more»

]]> 68e16542dab718b4dbdc34f3b7f6c4e3 https://medicaldevicecourses.com/activity/p/15656/ Wed, 15 May 2019 19:12:33 -0400 Indeed the ambiguity of GMP’s pose an issue with start-up companies that do not have a good foundation in a quality system. Ambiguity can be problematic in terms of having departments agree on a solution, the ambiguity can cause internal…   Read more»

]]> d9bd5701b58d569a82e308ba6b7fcf5b https://medicaldevicecourses.com/activity/p/15467/ Wed, 15 May 2019 19:06:40 -0400 Based out of my experience in the current company i am part of, is the funding as well just as the fellow user mentioned prior. Some companies are generally very cautious about funding new innovative projects unless there is substantial…   Read more»

]]> cebdedbc56f160293efb003b659b9625 https://medicaldevicecourses.com/activity/p/15440/ Wed, 15 May 2019 19:06:24 -0400 From work experience, I have not encountered a product failure in the current company that I am apart of, but I have participated in a root cause analysis based on a problem identified from our engineering team, a problem which…   Read more»

]]> af5e37ce6ec494e9606c8a89a0e3eeb5 https://medicaldevicecourses.com/activity/p/15439/ Wed, 15 May 2019 19:06:24 -0400 In a product’s life cycle as we all know consists of the following: Discovery and Innovation -> New Product Planning -> New Product Introduction -> Post-Launch Product Management. Each of these sections holds substantial significance in the product’s life cycle….   Read more»

]]> 931456f4c1a3994a0796671a113931dc https://medicaldevicecourses.com/activity/p/15132/ Wed, 15 May 2019 19:03:19 -0400 Just how it is mentioned by many prior in this discussion thread, if the equipment in the manufacturing plant is damaged to the point of ineffectiveness, a root cause analysis would need to be conducted to identify the problem, perform…   Read more»

]]> feafd762d9ac8143f6d33e7d7e8239bb https://medicaldevicecourses.com/activity/p/15130/ Wed, 15 May 2019 19:03:18 -0400 As previously mentioned by the fellow commentators, both the FDA and ISO requires a form of validation for medical devices. That being said, it all depends on the wording, this would make certain aspect of the validation process become more…   Read more»

]]> dca9411875237a0857f96cebd5436408 https://medicaldevicecourses.com/activity/p/15129/ Wed, 15 May 2019 19:03:17 -0400 I would agree with many that have commented in regards to the syringe filling process, vascular weaving line, antibiotic releasing hip stem manufacturing line, and wound healing growth factor and delivery device manufacturing line. Syringe Filling Process: IQ: Since the…   Read more»

]]> cb9c52caf03234bab3ea9ffa4ab7b22a https://medicaldevicecourses.com/activity/p/14910/ Wed, 15 May 2019 19:01:17 -0400 SOP’s are standard operation procedures, this is included on all realms of QA, manufacturing, clinical/non clinical testing etc. SOPs is the document that describes what a trained individual needs to do to run certain tests step-by-step to achieve certain results…   Read more»

]]> d0d8e4abf901a763c8d4b8ed4a28c99a https://medicaldevicecourses.com/activity/p/14908/ Wed, 15 May 2019 19:01:16 -0400 ECOs are used to make changes to the device if the SOP’s , suppliers, processes have been changed. ECO’s are set into place once the design controls are completed. ECO’s generally cost a large amount of money to actually process,…   Read more»

]]> 1ff2187a130d6fa6a37bb5767804143f https://medicaldevicecourses.com/activity/p/14907/ Wed, 15 May 2019 19:01:16 -0400 For medical devices class II and class III are required to have post market surveillance. This is a required procedure for medical device companies to initiate to keep track of any complaints or device failure. Post market surveillance is necessary…   Read more»

]]> 3ac15e46602b4f4f48a278e97bddcd74 https://medicaldevicecourses.com/activity/p/14771/ Wed, 15 May 2019 18:59:55 -0400 Verification = Inputs = Outputs Verification is completed after DAD and RA, this document shows the tests that were created for each specification or requirement in the DSD to verify that the design input meets the needs of the design…   Read more»

]]> ac3b113f39ec1c44981e194a114f5b97 https://medicaldevicecourses.com/activity/p/14770/ Wed, 15 May 2019 18:59:54 -0400 From my experience in working in the industry, the DHF i believe should be a living document along with the DMR. I can understand that the DHF is a history of the initial design history, SOP’s, and design control documents…   Read more»

]]> 510528dc9752a97c3f6352f3bc65e8ec https://medicaldevicecourses.com/activity/p/14622/ Wed, 15 May 2019 18:58:33 -0400 Essentially MEDDEV, NB-MED, and Competent Authority Guidance Documents all have their uses and advantages. However, considering the process of NB-MED bring written by notified bodies and MEDDEV written by competent authorities and lastly competent authority guidance documents written by individual…   Read more»

]]> fec50327e0096a4ecfb2dbd3a046cc78 https://medicaldevicecourses.com/activity/p/14621/ Wed, 15 May 2019 18:58:32 -0400 As mentioned be other fellow commentators, combinational medical device are much difficult to classify for those in the Notified Bodies, this is because according to the directives, the device would fall under either of the three categories, MDD, IVDD, and…   Read more»

]]> 8b728fff9799f713dd0e51b1a9d87a44 https://medicaldevicecourses.com/activity/p/14620/ Wed, 15 May 2019 18:58:32 -0400 From my experience, the company that i work for proceeded with releasing their medical device which is a vision testing device for diagnosis and early detection of retinal pathologies. The device was first submitted to obtain a CE Mark and…   Read more»

]]> 98028da008f54489309ee1e49cdfd603 https://medicaldevicecourses.com/activity/p/14514/ Wed, 15 May 2019 18:57:34 -0400 Currently i do not have any experience when it comes to the legal area. I agree with Dr. Simon’s recommendation on organizing a plan when meeting with the legal department either in-house or with another institution. This type of planning…   Read more»

]]> 833b0d7349ebe61b3856f0e6ba67c4c1 https://medicaldevicecourses.com/activity/p/14513/ Wed, 15 May 2019 18:57:34 -0400 Participation as mentioned by srg36, it is important for a company’s marketing strategy in the sense that it creates a welcoming feeling for new customers and shows that the medical device company is always open minded to hear to suggestions…   Read more»

]]> 1fcb272f6424cb0504358cd51fef9efb https://medicaldevicecourses.com/activity/p/14512/ Wed, 15 May 2019 18:57:33 -0400 Currently I am working in a medical device company that focuses on vision electrophysiology. The overall purpose of these vision testing systems is to aid optometrist and ophthalmologist diagnose their patients and use these devices for early detection. The two…   Read more»

]]> 9fa4993d9bb0377a02ec381db41b9eb5 https://medicaldevicecourses.com/activity/p/14353/ Wed, 15 May 2019 18:55:24 -0400 Verbal agreements are usually not used or in this case highly not recommended, this is because in the legal world, if it isn’t written down and notarized, verbal agreements cannot be used for legal reasons. Anyone can make promises but…   Read more»

]]> a6d7cbfa7cc18a42a4cc7ae96ee3d60d https://medicaldevicecourses.com/activity/p/14352/ Wed, 15 May 2019 18:55:23 -0400 Policies like those restricting to provide certain payed services to physicians for example is important to understand why they are established and practiced. These policies i believe are set to prevent corruption and biased opinion to the product. As mentioned…   Read more»

]]> 23fc2a07ee23958c3cd9d02d72e04946 https://medicaldevicecourses.com/activity/p/14351/ Wed, 15 May 2019 18:55:23 -0400 Overall the course was very informative and provided insight on the jobs available in the medical device industry. My current interest is to work in R&D, learning about the regulatory and quality sections of the medical device development process was…   Read more»

]]> 19fe50f652363eef0cb010ab784a70de https://medicaldevicecourses.com/activity/p/14212/ Wed, 15 May 2019 18:53:04 -0400 Working with certain people that you have a good relationship is always a good thing to have when it comes to getting work done and brainstorming ideas. The problem here is that there are moments where certain people become dependent…   Read more»

]]> 6e417a6302d36cd3f335479229840bda https://medicaldevicecourses.com/activity/p/14211/ Wed, 15 May 2019 18:53:04 -0400 Currently, I work in a functional organization structure. I am part of the Engineering department when I report to VP of engineering and I am part of an engineering team. We work closely with R&D, Manufacturing, Quality and Regulatory to…   Read more»

]]> 5c0d4ef3d33fb141da29e435bc64ec31 https://medicaldevicecourses.com/activity/p/14073/ Wed, 15 May 2019 18:51:39 -0400 I believe the following is what should be followed: 1) Low Severity Hazards: Should be mitigated but it can also be considered trivial or negligible, however it it is a common problem then it should be considered looked into because…   Read more»

]]> 624d30fa0f61355367c3381827fb7fe7 https://medicaldevicecourses.com/activity/p/14072/ Wed, 15 May 2019 18:51:39 -0400 I agree that Risk Management should be considered a living document to help a company document and keep track of their product post production. There are some issues that a product can experience after production their complaints can help a…   Read more»

]]> 0fd744a4c1b8f6eb19914551e9a22af6 https://medicaldevicecourses.com/activity/p/14071/ Wed, 15 May 2019 18:51:38 -0400 ISO 14971 regulation is directly co-related to with Risk Management, a system implemented to identify hazards and initiate a preventative action to ensure the medical device meets the regulatory requirements. Risk management revolves between a Risk Analysis procedure and FMECA…   Read more»

]]> 65cdd89d5eab42fde1dac83b069b69da https://medicaldevicecourses.com/activity/p/13935/ Wed, 15 May 2019 17:09:38 -0400 Validation is important to determine if the device meets the user needs and it’s intended uses, it helps the company determine if they are designing the right device. The FDA heavily focuses on Validation where technically during the entire design…   Read more»

]]> d15abd943e4b10c744ffeae750b2a03f https://medicaldevicecourses.com/activity/p/13934/ Wed, 15 May 2019 17:09:38 -0400 Design controls are an integral part of the success of any product, from the quality, performance, safety, reliability, performance standards and physical characteristics. Design controls looks into the inputs, outputs, validation, verification, and design planning, if there exists any poor…   Read more»

]]> 3999bc879163f07c6cc10ef2ddba9079 https://medicaldevicecourses.com/activity/p/13933/ Wed, 15 May 2019 17:09:37 -0400 Design Controls are not needed in the EU regulations, because they view a “snapshot” of that given point in time of the life of the device, they are searching for issues that could be present. The Technical File and Design…   Read more»

]]> a8c5329a1cbc34d22edbc6ad20af188b https://medicaldevicecourses.com/activity/p/13790/ Wed, 15 May 2019 17:08:13 -0400 From my previous experience with working with a team of engineers for a new product development, creating a Gantt chart is important at the early stages of the planning process. This chart helps ensure the team follows a timeline to…   Read more»

]]> a0dbeb43cbdb7f1257040919993e718c https://medicaldevicecourses.com/activity/p/13789/ Wed, 15 May 2019 17:08:13 -0400 As many have discussed previously, meeting minutes are very important when it comes to documentation on when decisions are made, this helps the team know who is held accountable if something were to go wrong. Not only to help one…   Read more»

]]> be3cb619e7f2e7a236408d0402a8ffd4 https://medicaldevicecourses.com/activity/p/13787/ Wed, 15 May 2019 17:08:12 -0400 Another country to heavily regulates medical devices such as their design controls is Japan which falls under Japan’s Pharmaceutical and Medical Device Agency (PMDA) and works in conjunction with the Ministry of Health, Labor and Welfare to ass new product…   Read more»

]]> b39ccfb2af58fbe7f965f4bb357a897f https://medicaldevicecourses.com/activity/p/13668/ Wed, 15 May 2019 17:07:05 -0400 I would choose to work as a Clinical Quality Assurance Auditor (CQA). CQA inspects the documents and processes clinical trial data and ensuring the testing follows proper guidelines as stated by good clinical practice (GCP). This role attracts my attention…   Read more»

]]> abc34d121cb0fa4ac93c3d005bc6b90a https://medicaldevicecourses.com/activity/p/13667/ Wed, 15 May 2019 17:07:05 -0400 I would agree with most of the pointers that are mentioned above. When it comes to the discussion of clinical trials are ethically correct, one should also consider that for most people that are in unique situations where a new…   Read more»

]]> 1e2f42db7ebad3b3f5c6f0dab5e2b5e1 https://medicaldevicecourses.com/activity/p/13658/ Wed, 15 May 2019 17:06:59 -0400 Based on my experience in the medical field as an EMT and as an Engineer, I can see how having a clinical background is paramount when it comes to working with doctors and other health care providers. I can say…   Read more»

]]> 89b4112bf14a0aa3939174f0233e6951 https://medicaldevicecourses.com/activity/p/13525/ Wed, 15 May 2019 17:05:39 -0400 Emotional intelligence is very important for companies to understand because it focuses on the customer’s emotions whether they are desiring to buy a product and what their current needs are. As discussed in the lecture, it was mentioned that the…   Read more»

]]> 06de09db7434900d2ea28a2e72be1d02 https://medicaldevicecourses.com/activity/p/13524/ Wed, 15 May 2019 17:05:38 -0400 Clever ways companies are venturing out to their customers or potential customers is via social media. Social media over the course of recent years has become a large platform where companies can communicate and interact with their customers both for…   Read more»

]]> 0add39cfc6dc59fc445f700299967c3f https://medicaldevicecourses.com/activity/p/13522/ Wed, 15 May 2019 17:05:37 -0400 Diopsys Mission Statement: Diopsys, Inc. is a medical instrumentation company dedicated to advances in preventive health care. The company specializes in the development and marketing of easy-to-use, non-invasive, patient-friendly diagnostic testing equipment utilizing electrophysiology. Diopsys understands the needs of the…   Read more»

]]> 20cde5323c3448a27a3af9706b73cff5 https://medicaldevicecourses.com/activity/p/13369/ Wed, 15 May 2019 17:04:21 -0400 It all depends on the given goal in mind or the business when it comes to LLP vs LLC, if you see a large future for your business and expand to other states then an LLC is a better option,…   Read more»

]]> 85ed8a8ec4df8088baf027aae409c96f https://medicaldevicecourses.com/activity/p/13368/ Wed, 15 May 2019 17:04:20 -0400 I did research on Google the following are my findings: Net Profit Margin (Q2)= 13.55% as of June 2017 Net profit margin is the percentage of revenue that was brought into the company as profit. Compared to 2016 which was…   Read more»

]]> 2023b05593f7b66e671e9c8fbaee83e2 https://medicaldevicecourses.com/activity/p/13367/ Wed, 15 May 2019 17:04:20 -0400 I agree with @bb254, if a mid-sized company is making $10 million in revenue per year, the company would generate a larger net worth if the company became an Inc corporation. As discussed in the previous discussion above, the long-run…   Read more»

]]> f167334d96d6ff9cfe22b5a41a49c081 https://medicaldevicecourses.com/activity/p/13228/ Wed, 15 May 2019 17:03:05 -0400 Based on my work experience with the current company i am with, i have worked with both Quality engineers and R&D engineers/scientists. The common problem i have seen is that projects in fact due get delayed because of check ups…   Read more»

]]> 99fbf2a335f52ce2542954e3a26fcd12 https://medicaldevicecourses.com/activity/p/13227/ Wed, 15 May 2019 17:03:04 -0400 In industry, there will always be a situation where departments will not be in the same page and this is because they have different objectives. In this case where the production of a new medical device is hindered by the…   Read more»

]]> 229308348f398913fd505537a9b0e5da https://medicaldevicecourses.com/activity/p/13226/ Wed, 15 May 2019 17:03:04 -0400 QA/QC is the integral part of any medical device or any product in general. The department is practically a checks and balances for the product to ensure it meets it’s intention without any defects. I can understand why companies may…   Read more»

]]> c0bc0c4cd584f5420a207052ee590fea https://medicaldevicecourses.com/activity/p/13077/ Wed, 15 May 2019 17:01:45 -0400 Throughout the years lawmakers and government departments such as the FDA have modified and added regulations to ensure that it tackles on all possible issues and meets their mission statement while maintaining a watchful eye on any possible failures in…   Read more»

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