https://medicaldevicecourses.com/members/kak33/activity/ Activity feed for kak33. Sat, 25 Apr 2026 02:21:41 -0400 https://buddypress.org/?v= en-US 30 hourly 2 d8fd9e8f0b490106295e4bfa6311379e https://medicaldevicecourses.com/activity/p/15892/ Wed, 15 May 2019 19:15:01 -0400 I agree with the comments above that costs are a major consideration when outsourcing clinical trials. When there is a discussion about cheaper costs in other countries, there is also a concern about the quality of work/materials. Just to expand…   Read more»

]]> d89fd2f351a63ae6fb4b7e7bafc5d1a9 https://medicaldevicecourses.com/activity/p/15884/ Wed, 15 May 2019 19:14:57 -0400 I think all undergraduate and graduate programs should considering adding courses like this because it gives students a glimpse of what it is like in the industry. My first job out of college as a R&D technical for a regenerative…   Read more»

]]> 98909a45f3114801cefc2866a87f58f0 https://medicaldevicecourses.com/activity/p/15785/ Wed, 15 May 2019 19:13:51 -0400 A couple of weeks ago my company had to place product on hold and initiate a CAPA because of nonconforming product. At a high level, a custom component from a supplier was not made to specification and was used to…   Read more»

]]> 74cb215f0163a3a102c022cca18479ce https://medicaldevicecourses.com/activity/p/15784/ Wed, 15 May 2019 19:13:51 -0400 In addition to internal audits to improve quality, my company also hosts internal kaizen trainings for various process to make continuous improvements. I have never heard of a kaizen until I joined this company but it is the Japanese word…   Read more»

]]> 3d0c0442cf0572632a9e1e27c0e9a31f https://medicaldevicecourses.com/activity/p/15690/ Wed, 15 May 2019 19:12:55 -0400 From my experience in the industry, this is a common problem in many departments. I’ve seen departments over loaded with work and the quality of the work that they are able to accomplish decreases. Sometimes people feel rushed and make…   Read more»

]]> 1637374ef506bb6f0f883b24930da236 https://medicaldevicecourses.com/activity/p/15680/ Wed, 15 May 2019 19:12:49 -0400 The FDA anticipates publishing a proposed rule early in 2019 on aligning the two. The FDA was instrumental in the revision of ISO 13485, most of the Part 820 regulation requirements are covered in ISO 13485. However, there are some…   Read more»

]]> 5224b8e9e7b9a2d02947a5260a1028e6 https://medicaldevicecourses.com/activity/p/15678/ Wed, 15 May 2019 19:12:48 -0400 My company performs a yearly review of our manufacturing practices. However, I did find a publication by the NSF about changing your quality culture and improving GMP behaviors. It steps the reader through identifying what needs to be changed, what…   Read more»

]]> f5cb4a5807efbbc6f31dbf0e43643048 https://medicaldevicecourses.com/activity/p/15247/ Wed, 15 May 2019 19:04:24 -0400 I think it can get tricky when talking about process revalidation and what is required to qualify the equipment to be used in the process. In my opinion, I don’t think you would need to revalidate the process in EVERY…   Read more»

]]> 4f7a9580958b65e940eb3c4ad5aa08a1 https://medicaldevicecourses.com/activity/p/15242/ Wed, 15 May 2019 19:04:21 -0400 I think we can all agree that it is better to be proactive in MOST, if not all situations for the best interest of the business. I think it is also important to note that by definition one of the…   Read more»

]]> fc8bfc65b0d4ad50f668f2bf31f3a47c https://medicaldevicecourses.com/activity/p/15238/ Wed, 15 May 2019 19:04:19 -0400 I feel that my undergraduate career prepared me to write technical reports more than protocols. I am confident in my writing abilities, however, I still feel like it is always a good idea to get an independent person to review…   Read more»

]]> 5daa5e1e0bc219de97f8d04365e311e6 https://medicaldevicecourses.com/activity/p/15009/ Wed, 15 May 2019 19:02:08 -0400 I think a SOP should be used during the research phase but if not, I think it MUST be used during development. This way the engineers would be able have some sort of traceability to know that the processes used…   Read more»

]]> ba4e27c5c53830672dcf1feaa6457e6a https://medicaldevicecourses.com/activity/p/15002/ Wed, 15 May 2019 19:02:05 -0400 In my experience, I add as much detail as possible to SOPs such that there is no room for interpretation because our processes are so tightly controlled. For example, right now I am developing a process to create Master and…   Read more»

]]> afb05bb60e6485ecbeb563eaaf80a7d4 https://medicaldevicecourses.com/activity/p/14999/ Wed, 15 May 2019 19:02:04 -0400 I currently work as a manufacturing engineer at a medical device company. My team is responsible for maintaining the on market device. We use DCPs (Design Change Process) to make any changes to the device, including labeling. People who join…   Read more»

]]> e29b321cef23f99a89db47f56d3c607a https://medicaldevicecourses.com/activity/p/14892/ Wed, 15 May 2019 19:01:07 -0400 My company doesn’t fill out a DSD. However, we do maintain a traceability matrix that shows all of the verification and validation activities completed for each design input. I think the level of up front detail that is presented with…   Read more»

]]> c55afd45328da1fac4f1df822d8cc65e https://medicaldevicecourses.com/activity/p/14890/ Wed, 15 May 2019 19:01:06 -0400 I currently work in manufacturing and I see a lot of instances when a design and process needs some form of verification or validation. We use verification activities to test and confirm that product meets the specific requirements of the…   Read more»

]]> d4b8a9e6b94be6d7670b827785289098 https://medicaldevicecourses.com/activity/p/14885/ Wed, 15 May 2019 19:01:03 -0400 I understand the idea of using the DHF as a living document to detail design and development plans and deliverables. However, at my company, once the product has been transferred, the DHF is sealed and any changes must be implemented…   Read more»

]]> 370212de2cf96ebb62ac4e71f8bec524 https://medicaldevicecourses.com/activity/p/14724/ Wed, 15 May 2019 18:59:31 -0400 I found this article that relates to the topic. It digs a little deeper as to WHY it actually takes so long go get devices approved in the US. According to the article, Innovative medical devices take significantly longer to…   Read more»

]]> c0a50d4dfcdfe150949b5bbca49c870b https://medicaldevicecourses.com/activity/p/14715/ Wed, 15 May 2019 18:59:26 -0400 Another notable difference is with post-market clinical follow-up. For the FDA, PMCF is only required for the highest risk devices. For CE Marking, however, all product families are required to have evidence of post-market clinical follow-up studies or a justification…   Read more»

]]> 1f21c33f1a680e282486faef3659e581 https://medicaldevicecourses.com/activity/p/14713/ Wed, 15 May 2019 18:59:25 -0400 There are differences in regulatory approach between the EU and the U.S.. Therefore; there are differences in device classification and we can not assume that meeting the requirements for the U.S. market would satisfy the EU requirements. Another example of…   Read more»

]]> 2f9133846454b3623b10978da43d94c3 https://medicaldevicecourses.com/activity/p/14574/ Wed, 15 May 2019 18:58:09 -0400 Beyond identifying a combination, I wanted to touch upon some of the challenges that surface when understanding the classification, and jurisdiction of these products. Common challenges include legal issues, marketing, premarket, post market, and cross labeling. Legal issues arise because…   Read more»

]]> 4c546a1c65fcc14cc6187a00bff5b47a https://medicaldevicecourses.com/activity/p/14572/ Wed, 15 May 2019 18:58:08 -0400 I am not very familiar with my companies marketing strategies. However, I do think we use a participation approach. At one of our all employee meetings last year a representative from the ER department of one of the largest hospitals…   Read more»

]]> c047951d3a2b9cb4a2c0b9af1f89f20b https://medicaldevicecourses.com/activity/p/14571/ Wed, 15 May 2019 18:58:07 -0400 I currently work for a Point of Care medical device company. My company focuses on the hand held type instead of the larger models. Based on my understanding of the market, PoCT is slow to launch new test types because…   Read more»

]]> f7a1f82b4608403f261fc3fd46ae6b48 https://medicaldevicecourses.com/activity/p/14477/ Wed, 15 May 2019 18:57:17 -0400 I think this course was very relevant and valuable. I currently work for a medical device company, so it was cool to see how things I do in practice aligns with regulation and applies to general concepts. I didn’t have…   Read more»

]]> 2efcd45cf3dc5cbd7df0185f0d56b429 https://medicaldevicecourses.com/activity/p/14466/ Wed, 15 May 2019 18:57:13 -0400 I work for a medical device company that manufactures blood analyzers. From my understanding of contract agreements, I believe my company would have to have contracts with Singapore as they are the main manufacturing location for one of our products….   Read more»

]]> d32adc504f7cd913c76e0cd0af4da7fb https://medicaldevicecourses.com/activity/p/14459/ Wed, 15 May 2019 18:57:10 -0400 I have not experienced this but there is an article on NJ. com that really dives into non compete agreements. It talks about the impact of these agreements on people who are seeking to switch jobs. “One-third of the engineers…   Read more»

]]> d76409623322627c49c504a8842fb0b9 https://medicaldevicecourses.com/activity/p/14291/ Wed, 15 May 2019 18:54:50 -0400 Personally, I have found it difficult to work with people I have friendship level relationships at work. We always get things done, but sometime you may need to critique someone’s work or push back on something to advocate for the…   Read more»

]]> 2eb339ce109267460a7663aa0bb7ac1f https://medicaldevicecourses.com/activity/p/14289/ Wed, 15 May 2019 18:54:48 -0400 I think my company operates with a functional organization structure where most of the decisions are made by the managers. There is also little communication between silos within my own department. We work on 2 different models of the medical…   Read more»

]]> f705b2a0f476814d1d4b50c3b60d815d https://medicaldevicecourses.com/activity/p/14288/ Wed, 15 May 2019 18:54:48 -0400 I read a Forbes article that sought to use a data driven approach to analyze if there are different skills required for senior executives. They asked 332,860 bosses, peers and subordinates to indicate which competencies, if done well, would have…   Read more»

]]> f653db53fcca98ee0816c378682791c5 https://medicaldevicecourses.com/activity/p/14120/ Wed, 15 May 2019 18:52:09 -0400 I work for a medical device company as a manufacturing engineer. It is part of every design change procedure to conduct a Cause and Mitigation Impact Assessment where we evaluate the risks associated with the proposed changes. There is a…   Read more»

]]> 0f3bf27aa5f8351e1a2704ab721524d7 https://medicaldevicecourses.com/activity/p/14115/ Wed, 15 May 2019 18:52:04 -0400 I agree that trying to predict extreme events is a critical mistake in risk management. Instead of trying to predict extreme scenarios, I think it would be better to focus on the consequences. Instead of trying to predict when a…   Read more»

]]> 13b8ff47b32cfe6ed6c8f1fb982053e3 https://medicaldevicecourses.com/activity/p/14113/ Wed, 15 May 2019 18:52:03 -0400 Another method used is Expected Damage-Cost Analysis (EDCA). This method evaluates how often different hazards occur and ultimately estimates the damage cost per year. Results also include suggestions for precautionary measures such as investments and design/planning. This method takes into…   Read more»

]]> 7401021f57ddb73613c60f7daff5a028 https://medicaldevicecourses.com/activity/p/13972/ Wed, 15 May 2019 17:10:02 -0400 At my company, we document user requirements in its own document. The user requirements also drive design input requirement and are linked via a trace. When an input requirement is changed or modified, we also evaluate potential impact to the…   Read more»

]]> 910ee908bb5aff5f74849201f0b6e7d5 https://medicaldevicecourses.com/activity/p/13970/ Wed, 15 May 2019 17:10:00 -0400 From a professionalism stand point, I think the gantt chart and team expectations are important, but I believe the risk management deliverables and the combined effort to identify input requirements. In my opinion these two things really get the ball…   Read more»

]]> 201e4427b7b5e0549d806723ea6f4ad0 https://medicaldevicecourses.com/activity/p/13968/ Wed, 15 May 2019 17:09:58 -0400 I work for a company that manufactures handheld blood analyzers. In addition to the verifications performed to ensure the device reads samples within given limits. There are some general functionality input requirements that the device must meet. For example, one…   Read more»

]]> a60858735ec906c45b518059b3f4df70 https://medicaldevicecourses.com/activity/p/13883/ Wed, 15 May 2019 17:09:05 -0400 In my experience, Supplier notification for custom components is extremely important for companies that outsource some of their components. At my company, it is required to send the supplier a notification of the updated specifications and they must sign to…   Read more»

]]> 3ff1caaa48a973d62fc9dc0dd1e1d98f https://medicaldevicecourses.com/activity/p/13876/ Wed, 15 May 2019 17:09:01 -0400 I currently work in the industry but I’ve had little experience creating and managing Gantt charts. One issue that I face EVERY TIME I make a chart is adding too much detail. Because I know so much about the process…   Read more»

]]> acd75cd8193280bcf19bfa1dde7e4278 https://medicaldevicecourses.com/activity/p/13875/ Wed, 15 May 2019 17:09:01 -0400 Of course in the medical device industry they say “if its not documented, it didn’t happen.” So capturing decisions made and the logic behind the scope of the discussion is always valuable. In my personal experience, I’ve worked on Design…   Read more»

]]> 36740f41bd57d8d01f97359352744895 https://medicaldevicecourses.com/activity/p/13708/ Wed, 15 May 2019 17:07:26 -0400 Similar to some posts above, I would also like to be an investigator. It seems like they are directly involved in the meat a potatoes of the trail. But I also think the IRB role is interesting as well. It…   Read more»

]]> 5e8a76cefe30b7c9de312b303a5924cd https://medicaldevicecourses.com/activity/p/13702/ Wed, 15 May 2019 17:07:23 -0400 According to Johns Hopkins, in the 1950’s the practice of obtaining informed consent from cell or tissue donors was essentially unknown among academic medical centers. But the Nuremberg Code was in place by 1947 as ethical principles for human experimentation….   Read more»

]]> d494ff1258962012db2985960c42d64d https://medicaldevicecourses.com/activity/p/13681/ Wed, 15 May 2019 17:07:13 -0400 I agree with the posts above that placebo trials are needed. However, the experiment design must be controlled in a way such that ethical concerns are mitigated. Ethical concerns arise when a proven effective treatment exists for fear that the…   Read more»

]]> 37029c1885c7e806025c77594a4d418c https://medicaldevicecourses.com/activity/p/13415/ Wed, 15 May 2019 17:04:42 -0400 According to LegalZoom, if the sons must create a new business since a sole proprietorship is non-transferable. Once the original sole proprietor dies and the business is transferred, all of the business’s assets must still pass through probate. The sons…   Read more»

]]> 27e6b5ce8a98e996ddf24527a767c26f https://medicaldevicecourses.com/activity/p/13414/ Wed, 15 May 2019 17:04:42 -0400 I read this article about how a company was ready to go public and I thought it was interesting. From what I understand going public must be a timely decision. Completing an IPO too early can have disastrous effects on…   Read more»

]]> 4ebdf81f96c57caad47811e4c245e02a https://medicaldevicecourses.com/activity/p/13413/ Wed, 15 May 2019 17:04:41 -0400 Abbott Laboratories reported revenues of $6.64 billion in 2Q17, exceeding the analysts’ estimates. Abbott stock gained more than 4% the day of its 2Q17 results release, on July 20, 2017. In 2Q17, Abbott reported EPS (earnings per share) of $0.62,…   Read more»

]]> 96779fa221c97435eb9bc5e9c11bb36e https://medicaldevicecourses.com/activity/p/13343/ Wed, 15 May 2019 17:04:08 -0400 Based on my experiences in the industry, the risk to quality isn’t because of incompetence or neglect. I believe it is mostly because of the pressures from project deadlines and teams not incorporating all relevant departments in project planning. For…   Read more»

]]> 74fad28d5b06f840483e5cf72d98ae86 https://medicaldevicecourses.com/activity/p/13335/ Wed, 15 May 2019 17:04:05 -0400 I have not participated in an audit from an audit stand point but I recently attended a weeklong training on the FDA’s Quality System Regulation by AAMI University. The trainings were hosted by FDA, consultants, and at least half the…   Read more»

]]> 618c57624b634abf10178824d9d48909 https://medicaldevicecourses.com/activity/p/13330/ Wed, 15 May 2019 17:03:57 -0400 I also work for a medical device company and I agree with the concerns above. I would also add a challenge that we face with design control quality is that they constantly make up new rules for us to follow…   Read more»

]]> 3381283e58684b30eea915ef9ee02a38 https://medicaldevicecourses.com/activity/p/13119/ Wed, 15 May 2019 17:02:06 -0400 I just became aware of all of the complications surrounding Johnson and Johnson’s vaginal mesh so I did some more reading. Transvaginal mesh products are sometimes used during hernia surgery or to repair pelvic organ prolapse or stress urinary incontinence….   Read more»

]]> 5b9430efa2b1d6b44ed27ae1640c1999 https://medicaldevicecourses.com/activity/p/13118/ Wed, 15 May 2019 17:02:05 -0400 The FDA posted an article 3 days ago entitled “FDA approves first continuous glucose monitoring system for adults not requiring blood sample calibration” The FreeStyle Libre Flash Glucose Monitoring System is a class III device by Abbott Diabetes so it…   Read more»

]]> 10e99c868586f92c5ebdf43bf488b7b4 https://medicaldevicecourses.com/activity/p/13116/ Wed, 15 May 2019 17:02:04 -0400 Another combination product on the market is a catheter with antimicrobial coating. They are used to lower the risk of catheter colonization and infection. The Foley catheter, for example is describe as “flexible tubular device that is inserted through the…   Read more»

]]> 6cd571b6571e5d5a7da1f99fba7032db https://medicaldevicecourses.com/activity/p/13047/ Wed, 15 May 2019 17:01:31 -0400 I have a friend that is currently transitioning from academic research to industry research. She said she is happier in her new role because she feels like she gets more feedback on her performance. Her job evaluates her performance frequently…   Read more»

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