https://medicaldevicecourses.com/members/krp67/activity/ Activity feed for krp67. Fri, 24 Apr 2026 18:41:04 -0400 https://buddypress.org/?v= en-US 30 hourly 2 20238ac64dc5c9fbf9564aaad8454a7f https://medicaldevicecourses.com/activity/p/17376/ Wed, 15 May 2019 21:38:58 -0400 CMPL stands for Civil Monetary Penalties Law. In general CMPL are as result of mistakes made wither directly or indirectly against the law. As a consequence monetary compensation is required to be free of the act committed and/or partially makes…   Read more»

]]> 4ec4ea956c6bebb213062fcd6aba2999 https://medicaldevicecourses.com/activity/p/17373/ Wed, 15 May 2019 21:38:56 -0400 In the paper we were given by Dr. Simon it stated that Patents help to protect your innovation when you are harvesting the fruits of your invention. However, how do you help protect your invention during the critical phase? This…   Read more»

]]> 5a0aadf31563ad9507049618ebe07029 https://medicaldevicecourses.com/activity/p/17370/ Wed, 15 May 2019 21:38:55 -0400 This is my second online class with Dr.Simon and I knew I would not be disappointed with the amount of information obtained form Dr. Simon. In particular to this course I learned the following: – Medical device development has a…   Read more»

]]> eda72cde6afa3104481686c794b81f05 https://medicaldevicecourses.com/activity/p/17229/ Wed, 15 May 2019 21:37:46 -0400 To be a PM for an matrix Organization, as stated by @rv347 is difficult due to more responsibility given to you, more time needed to complete tasks and overall need to love working. So to be a PM of Matrix…   Read more»

]]> 8e038f20e028cd68ae31df19c326f11a https://medicaldevicecourses.com/activity/p/17228/ Wed, 15 May 2019 21:37:45 -0400 As an intern I noticed that the organization structure was Matrix. However, I noticed a pro and con about the structure. The consequence of having an Matrix organization is that people tend to ask everyone for an answer when an…   Read more»

]]> e530b045f0d3e4dc4a2b859d1307ba13 https://medicaldevicecourses.com/activity/p/17145/ Wed, 15 May 2019 21:37:02 -0400 My interpretation of AFAP is twofold: Businesses are doing just enough to be competitive or Businesses are going above and beyond to be the best. In the medical device realm to be the best is to have the require ISO,…   Read more»

]]> 24d2b8b66c0e940147c8124b8d45b0d4 https://medicaldevicecourses.com/activity/p/17143/ Wed, 15 May 2019 21:37:01 -0400 The regulations are written by people who do this for their career. That means they need a form of compensation. The fee(s) are used to compensate the employees who help write these regulations. These regulations show the quality of product…   Read more»

]]> b3c5dee998b5a1e70e5767d039daf1b1 https://medicaldevicecourses.com/activity/p/17141/ Wed, 15 May 2019 21:37:00 -0400 For medical devices there is an ISO standard which is ISO 14971. ISO 14971 is the Application of Risk Management to medical devices. In general, it states the specification for manufacturers to identify the hazards associated with medical devices, including…   Read more»

]]> 5c830d35bf1c1d58cd7453daceaee86e https://medicaldevicecourses.com/activity/p/17058/ Wed, 15 May 2019 21:36:18 -0400 Being part of capstone instilled in me the practical and technical skills of writing a DDP and how you must use “shall” in the document. Also, if you make changes in one document say the DDP then you will have…   Read more»

]]> 05fc6d9b18dc7f67478c3a291dec8864 https://medicaldevicecourses.com/activity/p/17056/ Wed, 15 May 2019 21:36:17 -0400 At my internship theirs many design controls set in place to ensure we get good coatings on the ammunition we coat. For example after the bullets have been coated from a basket, I take three parts weigh them and then…   Read more»

]]> c4778437ef91b66241c228bd7a9cd3fe https://medicaldevicecourses.com/activity/p/17055/ Wed, 15 May 2019 21:36:17 -0400 From working at my internship I have had meetings in general and not at all related in terms of medical devices however, I notice that when meetings do take place they can be either exciting or boring. People from internship…   Read more»

]]> 26add3138e2423f5e83eed71ec890a65 https://medicaldevicecourses.com/activity/p/16956/ Wed, 15 May 2019 21:35:26 -0400 The regulations in the USA vs EU are stricter in terms of documentation. With that being said it seems that the FDA tends to expatriate the companies with documentation where EU is lenient. However, in terms of actual processes I…   Read more»

]]> 0261446c7a0726c09fff3dc6c4042dbe https://medicaldevicecourses.com/activity/p/16955/ Wed, 15 May 2019 21:35:26 -0400 I agree with the DID as being a rough blueprint to the customers input as @amd29 had stated. The example I disagree with because it does not compare to medical devices since their tends to be more regulations and scientific…   Read more»

]]> 96d6f9bb7a2cccadf9bb11c5fc3cb349 https://medicaldevicecourses.com/activity/p/16954/ Wed, 15 May 2019 21:35:25 -0400 When working in research one must have a lab notebook to document ones findings. There is not many rules to this living document however it should be clear and concise what you are doing for each experiment and/or discovery that…   Read more»

]]> 3fc8526d97a350caf9bb63433efea20b https://medicaldevicecourses.com/activity/p/16875/ Wed, 15 May 2019 21:34:44 -0400 The paradox seen here is people want a cure but they do not want to risk their lives for it. You ask the person given the clinical trials If they would risk their own life to save those for the…   Read more»

]]> a1f13238a9e8cfd2952eba927255c2e2 https://medicaldevicecourses.com/activity/p/16872/ Wed, 15 May 2019 21:34:43 -0400 I notice that one critical step was missed this discussion was taking place. FDA demands animal testing prior to even having clinical trials being a thought. Data collection of the drugs on animals has to be analyzed for efficacy, toxicity,…   Read more»

]]> c4bf082ab530f24cfee84bf5d274647e https://medicaldevicecourses.com/activity/p/16869/ Wed, 15 May 2019 21:34:41 -0400 Going to give a brief summary of the general job responsibilities of a CRA. CRAs is health-care professional who performs many activities related to medical research. Some of those activities can be keeping the GCP’s for monitoring the clinical trials…   Read more»

]]> 5ff18a6033725f8baae8f196425dd9a8 https://medicaldevicecourses.com/activity/p/16736/ Wed, 15 May 2019 19:42:06 -0400 Marketing to me was and still those tel-marketers calling me at 5:00 pm at night before eating dinner. They tend to be expatriating and annoying. However, It seems when it comes to medical devices the role of marketing is more…   Read more»

]]> ed4f2f582f1cf27759763c6b89fd3fb5 https://medicaldevicecourses.com/activity/p/16735/ Wed, 15 May 2019 19:42:06 -0400 This is a fascinating factor to point out in branding. Sometimes people buy products just because of the color, which may sound absurd but it happens. From a website called HelpScout dot com, they go over the “ Psychology of…   Read more»

]]> ff208a40251a7436630c5f3ddde5345d https://medicaldevicecourses.com/activity/p/16734/ Wed, 15 May 2019 19:42:05 -0400 As Dr. Simon has mentioned in his lecture this week there is 15 grand strategies for marketing. The grand strategy which I will briefly talk on is the Turnaround strategy. From various resources the turnaround strategy is used when a…   Read more»

]]> 209a136be2b0b8cceecff6a986af7128 https://medicaldevicecourses.com/activity/p/16621/ Wed, 15 May 2019 19:40:55 -0400 I choose Merck for the financial assessment: I found these results base doff Yahoo financial page for companies. Doing a brief financially assessment off 2016 since some data isn’t up for 2017 yet. Income Sheet: Gross Profit : 26,444,000 Net…   Read more»

]]> ebe6d359db441e252e3c82ef91f94dd7 https://medicaldevicecourses.com/activity/p/16618/ Wed, 15 May 2019 19:40:53 -0400 I have never thought to look at growth, revenue etc.. when even applying to a company. When I look for a job posting I typical look at the job based on requirements and the experience. I have already looked at…   Read more»

]]> 9bfffe35ce0c6e73ce4539cee8fc4d0f https://medicaldevicecourses.com/activity/p/16617/ Wed, 15 May 2019 19:40:53 -0400 I researched largest private companies in America and found Cargil ranked 1 as well as it brings a revenue of $109.7 Billion dollars. For a company so “big” I have never heard of it before until last semester in Bio…   Read more»

]]> 736b9dec9208d088a3fcd825fd50b8e4 https://medicaldevicecourses.com/activity/p/16539/ Wed, 15 May 2019 19:40:08 -0400 I see and feel the passion you have towards a very strong argument towards the relationship of physician and pharmaceutical companies. I believe what you are posing is indeed happening in the world we live today. It is the result…   Read more»

]]> 67da22e3977e28694df180ab97d2408d https://medicaldevicecourses.com/activity/p/16537/ Wed, 15 May 2019 19:40:06 -0400 The company I intern for has a NADCAP (National Aerospace and Defense Contractors Accreditation Program) certification for some of their tanks. This certification is an industry-managed approach to conformity assessment of special processes that brings together technical experts from prime…   Read more»

]]> b04733b3e4c8ec430b0a95bb0c7ef392 https://medicaldevicecourses.com/activity/p/16534/ Wed, 15 May 2019 19:40:05 -0400 In the last month or so at my Internship at Paramount Metal Finishings I have learned some about Quality Control. The company I intern for is not a medical device company however applications can be applied. The company takes military…   Read more»

]]> e3f14418cda1746ff131bb7f0fe7f24c https://medicaldevicecourses.com/activity/p/16426/ Wed, 15 May 2019 19:39:12 -0400 It seems like from an article I read the 510 K process is towards the CDRH center. CDRH employees have expressed concerns to the current 510 (K) program because some of the devices being evaluated are rather complex. The reviewers…   Read more»

]]> 7300d38f0398a339f6bf6dd72757b997 https://medicaldevicecourses.com/activity/p/16423/ Wed, 15 May 2019 19:39:05 -0400 A medical device that I can’t speak to much on because of IP is considered a combination product. It’s a diagnostic device which can accurately read small concentrations in the pico-scale. The device can use blood and or urine to…   Read more»

]]> 17a4f890c8e1ca393adcc2e9b8cf22ac https://medicaldevicecourses.com/activity/p/16419/ Wed, 15 May 2019 19:39:03 -0400 From doing some reading on the FDA website a ‘recall’ is when a manufacturer takes a correction or removal to address a problem with a medical device that violates FDA law. The first action called “correction” address a problem with…   Read more»

]]> 64dd7f9c599d69f2b2ea80973d401a59 https://medicaldevicecourses.com/activity/p/16312/ Wed, 15 May 2019 19:38:00 -0400 I have done research in academia but not for industry. Based on what Dr.Simon has stated about academia in terms of research is 100% true for the most part. The timeline for doing experiments and in general research is not…   Read more»

]]> 03e61e7dde898211fa0e37fec616084d https://medicaldevicecourses.com/activity/p/16310/ Wed, 15 May 2019 19:37:59 -0400 As a pet owner, my view on this matter is will have a hint of bias towards how I respond. For me animals that are considered to be pets in the house I tend to cringe when I think of…   Read more»

]]> c2d3d6222f7ecc294acaaf94d77fee2d https://medicaldevicecourses.com/activity/p/16209/ Wed, 15 May 2019 19:18:20 -0400 Out of the three listed objectives, achievable is the critical objective. This objective has to be based on a plethora of other sub-factors. The amount of time it will take, the number of employees a company has, do we have…   Read more»

]]> e946f5eb8a49c8aa4341b21be416d6e6 https://medicaldevicecourses.com/activity/p/16206/ Wed, 15 May 2019 19:18:18 -0400 In theory, the WBS is an ideal template to follow when working on a project. I agree that the WBS is pertinent to the success of a project. In reality, people do not always follow the WBS due to people…   Read more»

]]> 945a9b580087e796df96e3a1a3aceda7 https://medicaldevicecourses.com/activity/p/16205/ Wed, 15 May 2019 19:18:18 -0400 I agree with you manolo in terms of asking questions that are critical when initiating the start of a project. The important question to ask is the following: Whatever the project we are doing is there a market for the…   Read more»

]]> 2e8bcb13b1825db1701f54721c78de37 https://medicaldevicecourses.com/activity/p/16145/ Wed, 15 May 2019 19:17:39 -0400 Undeniably we can say that industry has a demand that is sometimes unreasonable wither it be time given for a project, the quantity of something to be mass produced. With industry “cut corners” tends to be at the expense of…   Read more»

]]> adea3bf14afaee657900c886d019c52e https://medicaldevicecourses.com/activity/p/16140/ Wed, 15 May 2019 19:17:36 -0400 People have been saying co-ops and internships however I found it most difficult to acquire these because I did not use my academic advisor to help me. Always speaks to your academic advisor they have the contacts to help you…   Read more»

]]> 064ee6d502b7300614681856b8e9dbbb https://medicaldevicecourses.com/activity/p/16134/ Wed, 15 May 2019 19:17:30 -0400 When I finally decided to take BME as a degree it came to the fact it had many different engineering disciplines associated with it. With many disciplines such as mechanical, chemical and electrical I knew this degree would give me…   Read more»

]]> 1449a9842a2773f2a0bfe414e668aa14 https://medicaldevicecourses.com/activity/p/15988/ Wed, 15 May 2019 19:15:55 -0400 For this week’s simulation, an NCMR report would definitely have to be filled out for CamTech. CamTech would hear complaints rapidly once they heard about the volatile smell from there pouches. The PM and associates would have to have a…   Read more»

]]> 7c47b28284ba642bc51a724fb8f994af https://medicaldevicecourses.com/activity/p/15855/ Wed, 15 May 2019 19:14:38 -0400 I would pick the broad category of being an investigator. More than likely be a medical device engineer of whatever the specified area of expertise, which the clinical trial is being done. I like solving problems, therefore, being an investigator…   Read more»

]]> 22d51cbaee5cdd7ab695ee71c1db9324 https://medicaldevicecourses.com/activity/p/15852/ Wed, 15 May 2019 19:14:35 -0400 From a website it stated, “Market Competition increased, with supply market seeing continuous mergers and acquisitions, resulting in consolidations and CROs”( clinical leader website). I think the reason for the outsourcing is because it may be to much work for…   Read more»

]]> 7c59c8e3315e797b878645ed19c34a26 https://medicaldevicecourses.com/activity/p/15851/ Wed, 15 May 2019 19:14:34 -0400 When I think of retention I think of elementary school days as to when students were retained because their grades were not adequate to advance the next grade or class. This is the negative connotation of the word. The positive…   Read more»

]]> dbf5c20a5b86eb9e86ec2b89d99b0cf5 https://medicaldevicecourses.com/activity/p/15724/ Wed, 15 May 2019 19:13:17 -0400 Root cause analysis (RCA) is a method of problem solving used for identifying the root causes of faults or problems. RCA has ‘general’ principals associated with it throughout many articles. 1. Define and describe properly the event or problem 2….   Read more»

]]> 28662e45d403036a658ae958486190c6 https://medicaldevicecourses.com/activity/p/15723/ Wed, 15 May 2019 19:13:17 -0400 For my Senior Design Project, we have to set-up a WBS. We use Microsoft Project Planner to monitor the tasks we have as well to see the critical path i.e(longest path for work to be done). However, this WBS doesn’t…   Read more»

]]> 8d35b47ba73d1091f802f725f9ceba93 https://medicaldevicecourses.com/activity/p/15591/ Wed, 15 May 2019 19:08:00 -0400 I agree with amin-sadig in terms of people misconstruing the data, it unethical obviously. We live in a corrupted world and people will do anything to get ahead or to look “good”. I agree that cost may not be uniform…   Read more»

]]> 36ee4781240a6c3527e2f8f9e5377326 https://medicaldevicecourses.com/activity/p/15590/ Wed, 15 May 2019 19:07:59 -0400 The way this question is stated isn’t clear and concise. The reason being is we have no information i.e(as mentioned before) about the project(s). We do not have an substantial information to qualitatively answer this question. However, I would take…   Read more»

]]> 65654217c86d448a6209a1cceff225a0 https://medicaldevicecourses.com/activity/p/15461/ Wed, 15 May 2019 19:06:37 -0400 I have no experience with this however, I can provide some insight. For the process of design transfer to be easier I believe status meetings should be done prior to the project being handed off to manufacturing or production. Manufacturing…   Read more»

]]> 01f4e56272f61cb0557dd0bfc6c2c186 https://medicaldevicecourses.com/activity/p/15458/ Wed, 15 May 2019 19:06:35 -0400 As mentioned above most have spoken on factors which have a negative outcome on the SV. However, there are positive factors which lead to a positive SV. One of those factors is to use the DHF (Design History File) ….   Read more»

]]> 15362e7f7853222d5d2675f67276dbfb https://medicaldevicecourses.com/activity/p/15451/ Wed, 15 May 2019 19:06:31 -0400 I disagree with the above statement because the planning phase of PM is devoted to acquiring the necessary components for the project. During executing phase, the project is immediately being worked on. However, there may be an adjustment in the…   Read more»

]]> cf2ca97debe5c1ec06a5d13b99af6172 https://medicaldevicecourses.com/activity/p/15373/ Wed, 15 May 2019 19:05:41 -0400 I have never worked for a medical device development company however, this topic is intuitive. This can be applied to any company and not just medical devices. Google and Amazon have become companies that I am sure to have gone…   Read more»

]]> d0db5381bd29f82312c9788e132f26ad https://medicaldevicecourses.com/activity/p/15372/ Wed, 15 May 2019 19:05:40 -0400 When it comes to a PMOA there are three regulatory sectors that can be exploited: Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation (CBER) and Center for Devices and Radiological Health (CDRH). With these centers or sectors,…   Read more»

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