https://medicaldevicecourses.com/members/dipanpatel/activity/ Activity feed for dipanpatel. Fri, 24 Apr 2026 17:34:39 -0400 https://buddypress.org/?v= en-US 30 hourly 2 38c3e81b6b0841d9fac20df4ae8edd73 https://medicaldevicecourses.com/activity/p/16043/ Wed, 15 May 2019 19:16:29 -0400 I very much appreciate this class. As especially because before I worked in the industry my notion were completely incorrect. After starting to working in the industry I realized that this class is one of the only classes that have…   Read more»

]]> 93240d865d90f39eaafc80661cc65d4c https://medicaldevicecourses.com/activity/p/16042/ Wed, 15 May 2019 19:16:29 -0400 The biggest determinants for the classification are one the basis for the risk determination. The second, the nature of the harm that may result from the use of the device, this is the biggest key in determining the class because…   Read more»

]]> 83cf8c9c2af52b0ba1f6b8e2c58c7355 https://medicaldevicecourses.com/activity/p/16041/ Wed, 15 May 2019 19:16:28 -0400 Good clinical practice is a guideline for conduct of clinical research. Even though these guidelines are available misconduct makes clinical research a highly vulnerable area to commit fraud. Fraud could be of various types and due to various reasons. Whatever…   Read more»

]]> fade5df963261dd4c443537540230d22 https://medicaldevicecourses.com/activity/p/15922/ Wed, 15 May 2019 19:15:17 -0400 More and more companies are outsourcing their clinical trials due to the advantages in cost efficiency. But that isn’t the only advantage. The countries are able to provide fast recruitment of patients, good data quality, and GCP compliant activities. These…   Read more»

]]> 5b4eac9f03541e97e4857cdd6073b405 https://medicaldevicecourses.com/activity/p/15921/ Wed, 15 May 2019 19:15:17 -0400 The biggest advantage to in hiring CRO is the expertise and experience that the company would provide. Do to their sole role in the industry. And the second biggest would be its cost efficiency of hiring an outside company to…   Read more»

]]> d75bcebc7ed746b86e1e4837f2059ed9 https://medicaldevicecourses.com/activity/p/15748/ Wed, 15 May 2019 19:13:31 -0400 There is a big advantage of besides being prepared. As an employee involved in improving and auditing the company’s procedures, there is a double insight that can help the audit in seeing if the improvements are actually viable. Another is…   Read more»

]]> a334f16a8b75152ba91c09c78f3c9687 https://medicaldevicecourses.com/activity/p/15746/ Wed, 15 May 2019 19:13:30 -0400 Usually, non-conformities occur during the production process but from what I have experienced it is usually a minute error by a production worker on the production line. Usually, the product is salvageable but it can be scrapped. However, in a…   Read more»

]]> 05de855acd4b994fd922dd6fc118b1d0 https://medicaldevicecourses.com/activity/p/15745/ Wed, 15 May 2019 19:13:30 -0400 Something that my company did and is currently doing to improve GMP is overhauling a remediation that looks over every procedure and important documents used in the management system and going over it with a fine tooth comb. Doing so…   Read more»

]]> 487409df2ceac16eef1c514b7f297ade https://medicaldevicecourses.com/activity/p/15663/ Wed, 15 May 2019 19:12:39 -0400 This situation is evident in smaller companies. Auditing your own work defeats the purpose this is why private auditing firms are hired to access the companies process. However, another practice that seems to be getting more popular is hiring many…   Read more»

]]> e7e346912d280663b3a39fde4cc5937c https://medicaldevicecourses.com/activity/p/15662/ Wed, 15 May 2019 19:12:38 -0400 In layman terms, the biggest difference is that a Corrective is immediate fix and is more of a one time or a defect of a process. Whereas a corrective action is a method of solving a reoccurring issue that is…   Read more»

]]> ade4e94eb50a0fbd535edec52f4c1cac https://medicaldevicecourses.com/activity/p/15661/ Wed, 15 May 2019 19:12:37 -0400 Besides being a document, a CAPA is multiple phases that a company goes through the implement what the CAPA is stating. Overall it has an identification, evaluation, and investigation of a deviation, of procedures. It can also be a tool…   Read more»

]]> 9a0bf24b4a54657b7b28e3772c293038 https://medicaldevicecourses.com/activity/p/15622/ Wed, 15 May 2019 19:08:20 -0400 During the maturity, stage sales will plateau, and the profit margins of your products will begin to decline. This is typically caused by a number of factors come this can be market saturation or other alternative solution to what said…   Read more»

]]> 21d4a0b4066d71fa5ec0832700c8e971 https://medicaldevicecourses.com/activity/p/15620/ Wed, 15 May 2019 19:08:19 -0400 The most expensive phase I believe is the development phase and only slight lead to the introduction phase. The development phase takes the most resources when It comes to new flagship products. The phase needs ample testing and qualification which…   Read more»

]]> 1d82c331905a52971d8b03371929aa73 https://medicaldevicecourses.com/activity/p/15618/ Wed, 15 May 2019 19:08:18 -0400 A procedure that I have noticed that has seemed to work is market research on each product line the company offers. The research is presented to of concern departments and an assessment is taken. Products that have shown a decline…   Read more»

]]> f7ba865285cd62465f730f07cadb4e3d https://medicaldevicecourses.com/activity/p/15564/ Wed, 15 May 2019 19:07:41 -0400 A person business and technical acumen are very important in term of relation to deals. Each party is taking a risk for each other to work together, and the knowledge provides confidence that the deal will be executed effectively. The…   Read more»

]]> 92829421b1498c48ed4e34e7506fd91c https://medicaldevicecourses.com/activity/p/15562/ Wed, 15 May 2019 19:07:40 -0400 In my experience, I believe that staying informed about the industry is one of the most important aspects. The first and biggest reason is knowing your competition how one can make sure that our product is best in its market….   Read more»

]]> 0952b69fa6e647a2624267b2c9d75761 https://medicaldevicecourses.com/activity/p/15548/ Wed, 15 May 2019 19:07:31 -0400 In my experience, the leadership and their motivation have been the biggest hurdle for the innovation and research for the company I work for. My company produces products that are widely used and very successful in their niche. This has…   Read more»

]]> 0ed8785c6fa7171cf937082ce56cc5f1 https://medicaldevicecourses.com/activity/p/15279/ Wed, 15 May 2019 19:04:46 -0400 Efficient and proper validation is key for proper functionality. The validation I have seen that very key in certain institutions are testing of every component in terms of material/functional validation, leak functionality, various chemical coating functionality and shelf life. The…   Read more»

]]> 4b9535bfe41d0a52533bafdd9dced556 https://medicaldevicecourses.com/activity/p/15278/ Wed, 15 May 2019 19:04:45 -0400 I agree with your justification but to take a step further, I believe the reevaluation should be done as often as possible. Granted a full reevaluation can be costly and unnecessary but it can be preventative for future issues. Just…   Read more»

]]> e057d0413f6ae05f8c46899623dfde80 https://medicaldevicecourses.com/activity/p/15276/ Wed, 15 May 2019 19:04:44 -0400 I very much agree with your statement. Internal audits are essential for keeping an up to date quality system. Implementing CAPA as a result of internal audits issues will help keep the company out of trouble. If for example, a…   Read more»

]]> 99901e21dacb47ab48d1f951716dd532 https://medicaldevicecourses.com/activity/p/15215/ Wed, 15 May 2019 19:04:02 -0400 I agree with hm243 that a reevaluation has more benefits than pitfalls when observing the various location of equipment use. However when multiple locations are set and frequent then a complete evaluation may not be necessary. If the equipment is…   Read more»

]]> 1bf365e7965b411f750dd93055844f32 https://medicaldevicecourses.com/activity/p/15213/ Wed, 15 May 2019 19:04:01 -0400 I believe is always beneficial to be proactive rather than reactive. In a reactive system you solve matters as they arise, this can lead to possible beneficial changes. However, solving matters before they become an issue will generally lead to…   Read more»

]]> afa173e49bc7c2ef13e178259ee38318 https://medicaldevicecourses.com/activity/p/15206/ Wed, 15 May 2019 19:03:58 -0400 I agree that technical writing is an essential skill that all engineers should have. Mandating classes that help students practice this skill will be a long-term benefit. Most communication especially interdepartmental paper-work uses written documentation as a primary communication tool….   Read more»

]]> 961dac8f3cce27a621725a4539fd6d07 https://medicaldevicecourses.com/activity/p/15055/ Wed, 15 May 2019 19:02:38 -0400 I may be misunderstanding your question, but revised documents should always be updated. If any other document references the changed document, then that document should also be checked for any necessary changes. No document should be outdated, especially in a…   Read more»

]]> 65168885f2cc70bae99fdad848e65730 https://medicaldevicecourses.com/activity/p/15052/ Wed, 15 May 2019 19:02:36 -0400 The FDA provides guidelines on validation processes with the purpose to ensure varied inputs lead to consistent and high-quality results. The process is tailored to each device. The customer and user need to be complied with. The safety and outcome…   Read more»

]]> 86a927cab4aa6c4d9570a640501a49b1 https://medicaldevicecourses.com/activity/p/15045/ Wed, 15 May 2019 19:02:33 -0400 The point of a QMS helps coordinate and give instruction to an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency. Keeping that in mind I believe that the organization that utilizes the 5 different…   Read more»

]]> e5fa282fd7ad74778d052258048efdcf https://medicaldevicecourses.com/activity/p/15000/ Wed, 15 May 2019 19:02:04 -0400 A particular change order that occurred was that my companies supplier for a certain plastic was changed. The difference was very slight but however, proper protocol is very important. Therefore an ECO was issued due to the change in the…   Read more»

]]> 843f4ec144524cf11c56e4f932485e0f https://medicaldevicecourses.com/activity/p/14996/ Wed, 15 May 2019 19:02:02 -0400 When writing SOPs, detail is very important. Your manager is correct, a random person should be able to complete the procedure. However, the in-depth details should also be concise. A concise and detailed procedure is more efficient that unnecessary words….   Read more»

]]> 1b0da527fffcac826767070e1369d61d https://medicaldevicecourses.com/activity/p/14995/ Wed, 15 May 2019 19:02:02 -0400 SOPs contain the regularly recurring work processes that are to be conducted within an organization. It states the activities that are to be performed to facilitate consistency.The use of SOPs minimizes variation and promotes through repeatable results. These guidelines are…   Read more»

]]> b534f7f0367a0606f27345a4306b4987 https://medicaldevicecourses.com/activity/p/14850/ Wed, 15 May 2019 19:00:46 -0400 I agree with your method of using a regression test to save resources. But this might not always identify the issue. By using a less involved method first and then later a more involved re-executing full verification and validation protocols…   Read more»

]]> 8d61dd29d3816543e53236d8156e5ab9 https://medicaldevicecourses.com/activity/p/14841/ Wed, 15 May 2019 19:00:41 -0400 I believe comparing the two documents and ranking them in terms of more usefulness might not be the best because the DHF is used widely by the FDA and Technical File and Medical Device (MDD) are for the Medical Device…   Read more»

]]> 14cfd92e67768864e993cdaae6b742b0 https://medicaldevicecourses.com/activity/p/14834/ Wed, 15 May 2019 19:00:37 -0400 The company the I work for uses a similar document that you stated. Using an excel spreadsheet with necessary columns to fulfill. I believe the method or specific document used can be irrelevant if the company uses their own efficient…   Read more»

]]> 1b2c2298a11211f335ba0766a16aa265 https://medicaldevicecourses.com/activity/p/14761/ Wed, 15 May 2019 18:59:50 -0400 The one big difference in classification I see between the FDA and the EMA is the class II classification. In the US, around 25 percent of the class II devices do not go through a clinical trial, whereas the other…   Read more»

]]> 61856cc81a1f1fe0d94104dbf3c171f2 https://medicaldevicecourses.com/activity/p/14759/ Wed, 15 May 2019 18:59:48 -0400 I believe the Guidance MEDDEVs is an important guideline. First and foremost they are drafted by the proper authorities that are in charge of being a safeguard for the public health, and guidelines that have that in mind will undoubtedly…   Read more»

]]> 609fcbf895ccc191aa49b76e3ce36235 https://medicaldevicecourses.com/activity/p/14756/ Wed, 15 May 2019 18:59:47 -0400 There are big differences between the Design History File, 510k Submission, and the Technical File. The design history file is an FDA regulation that talks about the design controls and the changes and additions that have occurred from the time…   Read more»

]]> a9011bf34a27597062d8de9417df190f https://medicaldevicecourses.com/activity/p/14415/ Wed, 15 May 2019 18:55:55 -0400 When it comes to business then verbal contracts should never be considered. Fighting this in court is very difficult when it turned into a he said/she said. One way to prove is the proof expenses and proof of services. The…   Read more»

]]> 8734156ab37da7a60ec16ff085d6c6fc https://medicaldevicecourses.com/activity/p/14414/ Wed, 15 May 2019 18:55:54 -0400 I do not think this is an over-restriction. These types of restriction are needed to keep the overall benefits in mind, instead of doctors being influenced by gift. The gift can easily be seen as bribes and this is a…   Read more»

]]> cb75f674fe62b605d8471898b9f78364 https://medicaldevicecourses.com/activity/p/14413/ Wed, 15 May 2019 18:55:54 -0400 An NDA is a contract of confidentiality, where a patent is a protection of intellectual property. Contracts are enforced differently in various states and very much matter solely on how well it is written if the contract is broken: it…   Read more»

]]> 9ba319389074b4f7198c17ceb99d9899 https://medicaldevicecourses.com/activity/p/14286/ Wed, 15 May 2019 18:54:46 -0400 Corporate culture represents the professional values a company adopts that dictate how it interacts with employees, vendors, partners and clients. An effect organization in a corporation can lead to a positive company culture. Culture relates to the people of the…   Read more»

]]> c4221425060fcc6d96e07906c0d889b3 https://medicaldevicecourses.com/activity/p/14285/ Wed, 15 May 2019 18:54:45 -0400 As a project manager, I believe a matrix organizational style would be the hardest or a more involved method to execute. The first aspect that makes this a more difficult organization is the presence of constant tensions between functional manager…   Read more»

]]> c629996778f4a4065b4ebe277df3ffc3 https://medicaldevicecourses.com/activity/p/14284/ Wed, 15 May 2019 18:54:45 -0400 Depending on the size of the company, its resources and number of projects the company holds can influence the best type of organizational method. For smaller businesses a project bases organizational structure I think works best. Project organizational structure refers…   Read more»

]]> b08859513bf975679f0b526528a6b59d https://medicaldevicecourses.com/activity/p/14161/ Wed, 15 May 2019 18:52:37 -0400 I agree with this post that labels should only be used as a last resort of precaution use. Product should go through immense testing and make sure there are no risk involved in using the product in its intended use….   Read more»

]]> b89af0e0ac2289adc314ea798b013c68 https://medicaldevicecourses.com/activity/p/14159/ Wed, 15 May 2019 18:52:36 -0400 I also agree with the 4th example being a very important aspect of risk management. When a company conducts it own identification of risks and test they try to be very thorough. However, a company cannot identify all risk and…   Read more»

]]> c8522bbcf84350e66817b5431d910f79 https://medicaldevicecourses.com/activity/p/14157/ Wed, 15 May 2019 18:52:35 -0400 The cost of regulation I believe is just. Companies pay millions of dollars in applications and fees in the process of releasing their product. These expenses pay for testing and regulations processed done on the product,and also to the subscription…   Read more»

]]> a90fc12bf2d65c228805f4764c093f7f https://medicaldevicecourses.com/activity/p/13975/ Wed, 15 May 2019 17:10:03 -0400 I have not been part of designs review in industry. However, last year a group of BME students and I applied for a URI grant and wanted to start our own project. We had design review meeting for each stage,…   Read more»

]]> 381641956ff64f611e493859b6217c5f https://medicaldevicecourses.com/activity/p/13974/ Wed, 15 May 2019 17:10:03 -0400 I am currently Senior at NJIT taking my Capstone class, which is our senior design class. The purpose of this class is to simulate real-world medical device processes to produce a product. Our professor look at our Gantt chart to…   Read more»

]]> 4596e5dde364a790c7b815a2c5d6f766 https://medicaldevicecourses.com/activity/p/13973/ Wed, 15 May 2019 17:10:02 -0400 Design controls designates the application of a proper process or method for the developmend of a product. It is mandatory to implement controls when designing and developing products within regulated industries such as medical devices. “The Food and Drug Administration…   Read more»

]]> 75259adf8f6c6731e0980855812a596b https://medicaldevicecourses.com/activity/p/13919/ Wed, 15 May 2019 17:09:24 -0400 I am currently a senior in Capstone. The procedures that we are exposed to when it comes to Customer Needs, Business Requirements and test plan is meant to mimic that of the industry. Formatting that class in more of an…   Read more»

]]> 31353a7b1aa515207b7e514af4ecbd70 https://medicaldevicecourses.com/activity/p/13860/ Wed, 15 May 2019 17:08:53 -0400 Being preparing for an audit is the best way to tackle an assessment. The first way to prepare is to actively start early. As DHF is being processes starting your traceability matrix from day one will make is a lot…   Read more»

]]> a8e3343a7e953b6b9146c895560c0afa https://medicaldevicecourses.com/activity/p/13855/ Wed, 15 May 2019 17:08:50 -0400 Taking minutes is an important aspect of meetings. The biggest legal reason of minutes is that it can be considered as a legal document. The minutes contain the action of the company and important action details. This means that this…   Read more»

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