Medical Device Courses | rd389 | Activity https://medicaldevicecourses.com/members/rd389/activity/ Activity feed for rd389. Fri, 24 Apr 2026 16:55:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 ce23f287ef2f5d87176bf418b216b120 rd389 replied to the topic "Factors to consider when executing the NDA" - https://medicaldevicecourses.com/activity/p/14501/ Wed, 15 May 2019 18:57:28 -0400 When you go to work for a company that requires you to sign an NDA, or you are a company looking to hire employees under a nondisclosure agreement, you will generally see at least five basic elements in the nondisclosure…   Read more»

]]> 715783c2266c673400bd5f0f038aff06 rd389 replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/14500/ Wed, 15 May 2019 18:57:28 -0400 The best thing about this course is that it gives us (students) the practical feeling and more understanding about the industry and how it works. Rather than other courses, it gives us opportunity to work in a team and how…   Read more»

]]> fe2438cd4eef03968f1ef06ae2285b1b rd389 replied to the topic "Restrictions for physician's gifts" - https://medicaldevicecourses.com/activity/p/14499/ Wed, 15 May 2019 18:57:27 -0400 I think that is little absurd that physician’s wife meal is not getting paid off. But then again why is physician’s wife in the meeting? I mean usually these meetings are highly confidential so personally I don’t understand the whole…   Read more»

]]> 07181cc976609628a456055255db2cef rd389 replied to the topic "Written Agreement v/s Verbal Agreement" - https://medicaldevicecourses.com/activity/p/14498/ Wed, 15 May 2019 18:57:27 -0400 The main difference is that written can be proven in court while oral might be little harder to do so unless you have a witness. Even then it might be tough. I don’t think it is wise to start up…   Read more»

]]> cab61c11012c398fde9b858eb2745604 rd389 replied to the topic "Organization Type vs. Effectiveness" - https://medicaldevicecourses.com/activity/p/14439/ Wed, 15 May 2019 18:56:58 -0400 Just like you, I have worked in both the structure too. In my opinion, I definitely liked the small organization where everyone is doing everything. Because, in the absence of one, other knows what is going on and how to…   Read more»

]]> 2d4d4cb51a35c498a0b65d76eee37aa2 rd389 replied to the topic "Collaboration projects" - https://medicaldevicecourses.com/activity/p/14411/ Wed, 15 May 2019 18:55:52 -0400 I would consider a Product Organizational Structure for collaboration projects. In this structure, managers report to head of the company and analysts report to managers. Their main idea is the product line. Therefore, their main goal is product line too….   Read more»

]]> 63d0db2b49c296081af558cfe14abf87 rd389 replied to the topic "Forming a Project Team" - https://medicaldevicecourses.com/activity/p/14409/ Wed, 15 May 2019 18:55:51 -0400 In my opinion, it should be both. Having departmental knowledge is very crucial in forming a team since that person needs to know in and out about every little thing about the department and how to do it. But when…   Read more»

]]> dc0ff53a0d47fd4d549a1828971b7df3 rd389 replied to the topic "Risk Identification" - https://medicaldevicecourses.com/activity/p/14408/ Wed, 15 May 2019 18:55:51 -0400 Documentation review is one of the main risk management analysis. Since the place I work uses all written documentations and no electronic, documentation review and should be under FDA regulated therefore, documentation review is very very important.

]]> 74375727cdc57a83d1bc147e9ecef8e3 rd389 replied to the topic "Expense of Regulations" - https://medicaldevicecourses.com/activity/p/14407/ Wed, 15 May 2019 18:55:50 -0400 Calibration, maintenance, safety inspections, regulations and standards all cost money but they are necessary to do it. Subscribing to these databases are simply an indispensability. If they are not charged then corners will be cut and for standards of this…   Read more»

]]> bed7507632b174e2bf8a90680c4a0872 rd389 replied to the topic "Factors Contributing to Risk Values" - https://medicaldevicecourses.com/activity/p/14188/ Wed, 15 May 2019 18:52:52 -0400 Factors contributing the risk index numbers can be divided into three different group: A. Overall context such as scientific unknowns, varying susceptibility to risk, positive feedback, and loss of safety margins. B. Human factors such as social dynamics, conflicts of…   Read more»

]]> 56a5f900653a0a1f14ea1fc84f202afc rd389 replied to the topic "Manage Risk" - https://medicaldevicecourses.com/activity/p/14182/ Wed, 15 May 2019 18:52:48 -0400 I dont think I would give any option low severity because in risk management everything is equally important. You can not have less acceptance while moderate high mitigation. But I would definitely give highest severity to transference. DUring anytime in…   Read more»

]]> 17ea08721021f7cdddb6a38ebf9eeb8e rd389 replied to the topic "Risk Management Mistakes" - https://medicaldevicecourses.com/activity/p/14179/ Wed, 15 May 2019 18:52:46 -0400 Risk management is not a lifecycle process! I totally agree to this that company should take care of risk management not only in the beginning of the production but during entire time of the production. Biggest example of this is…   Read more»

]]> 6fa668f3f8794ebb65311967b04cdb7a rd389 replied to the topic "What are Design Controls?" - https://medicaldevicecourses.com/activity/p/14053/ Wed, 15 May 2019 18:51:28 -0400 Design controls designates the application of a formal methodology to the conduct of product development activities. It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries (e.g. medical devices). Because design controls…   Read more»

]]> db90a67641f5e725f3060b185f262b00 rd389 replied to the topic "Design Verification & Validation vs Clinical & Pre-Clinical Trials" - https://medicaldevicecourses.com/activity/p/14048/ Wed, 15 May 2019 18:51:25 -0400 There are bunch of medical device that does not need clinical trial. Anything that has external use usually does not need medical device such as stretcher, medical gloves, assistive cane, walker, and other bunch of them.

]]> 0c9a593bdf7fcf0f9fc58eb8b01114f0 rd389 replied to the topic "Consequences Of Insufficient Design Controls" - https://medicaldevicecourses.com/activity/p/14034/ Wed, 15 May 2019 18:51:16 -0400 Issues with design controls: · assessing new product ideas · training and retraining of design managers and design staff · use of consultants · evaluation of the design process · product evaluation, including third party product certification and approvals ·…   Read more»

]]> fd1af0bc3fce5cb3b980ff431ca8ca0a rd389 replied to the topic "When is validation is not required?" - https://medicaldevicecourses.com/activity/p/13930/ Wed, 15 May 2019 17:09:30 -0400 Validation may not be necessary for all the reasons listed above but it’s still better to perform them as it keeps the team and the design on one page. If something changes then it can definitely be verified in the…   Read more»

]]> 4807352809e055e9991ff312feeb10e1 rd389 replied to the topic "How to ensure your DHF is audit ready ?" - https://medicaldevicecourses.com/activity/p/13927/ Wed, 15 May 2019 17:09:29 -0400 I haven’t really had experience dealing with DHF documents but in the past we have kept all our important documents in SharePoint and that has been very helpful. It provided us a place to upload and make the latest documents…   Read more»

]]> d374ed58f029458d8fead735b0b1f914 rd389 replied to the topic "Design Transfer" - https://medicaldevicecourses.com/activity/p/13920/ Wed, 15 May 2019 17:09:25 -0400 If I am running a company, I would prefer to outsource the design transfer to lower the labor costs, real estates and plant costs, fewer regulations and much more. With that, as a precaution, I would also first send a…   Read more»

]]> 0345dad72fd70c65a14c04b9d2565743 rd389 replied to the topic "Discussion Topic: Having a "clinical background"" - https://medicaldevicecourses.com/activity/p/13671/ Wed, 15 May 2019 17:07:07 -0400 I don’t think it is necessary although, having clinical background would certainly help. Every place that hires a new employee will go through the training and that should cover up whatever they are expected to do. Therefore, it is not…   Read more»

]]> e923c7c4a033382d778f2694b825932c rd389 replied to the topic "Clinical Studies" - https://medicaldevicecourses.com/activity/p/13670/ Wed, 15 May 2019 17:07:07 -0400 I 100% believe clinical studies are important but in my experience, I have learned that a lot of mistakes happen. Either it is human study or animal study. Frankly, animal study more often than human, may be because no animal…   Read more»

]]> 5e10ca054552464efa27b170b2071b96 rd389 replied to the topic "Informed consent: What if Henrietta Lacks checked No for research use?" - https://medicaldevicecourses.com/activity/p/13669/ Wed, 15 May 2019 17:07:06 -0400 Well as of today consent is most important thing in medical field. Whether we like it or not, approve it or not, it will be there and i feel it is definitely not going anywhere. I am very much behind…   Read more»

]]> c3a75b45c834d63528ba461221c17b8c rd389 replied to the topic "Discussion Topic: The Fifth "P" of Marketing" - https://medicaldevicecourses.com/activity/p/13646/ Wed, 15 May 2019 17:06:52 -0400 I am going to take over here the example of cars. I really liked the advertisement on TV of Chevvy’s. Customers are basically asked to drive an unknown car or just sit and feel the car or check out the…   Read more»

]]> f62b547f45cf9857429c8df5a8aeccb7 rd389 replied to the topic "Fuzz before launch of product." - https://medicaldevicecourses.com/activity/p/13643/ Wed, 15 May 2019 17:06:50 -0400 One another way a company can showcase the medical device is via a video demonstration. Along with conferences and summits, companies can make these videos available on social media websites. There has been countless number of times where I have…   Read more»

]]> 5442709876c04179cbdfb13a6fd3d2c8 rd389 replied to the topic "The Expert" - https://medicaldevicecourses.com/activity/p/13642/ Wed, 15 May 2019 17:06:50 -0400 The link did not work But i could found the video on youtube. This video is hilarious but of course little exaggerated. Anyway, I have had not much of an interaction with the clients similar to like this. But I…   Read more»

]]> 70dfdc43e809d5ed05d3273f8016938b rd389 replied to the topic "Types of Corporations" - https://medicaldevicecourses.com/activity/p/13498/ Wed, 15 May 2019 17:05:25 -0400 If I am the only owner, I would prefer to register an LLC because of low risk and less hassle of the taxes. If the company is product based, and needs more time to focus on production or manufacture than…   Read more»

]]> 5e92e3a58f6bc85e61836ce026268175 rd389 replied to the topic "Partnership characteristics" - https://medicaldevicecourses.com/activity/p/13485/ Wed, 15 May 2019 17:05:17 -0400 I would not prefer getting into a partnership because even when the ideologies are the same, the execution will always be different. Being in a partnership does offer low risk and support but views do change from time to time…   Read more»

]]> fb848a8800c8c62fb0fc6cfbbcbcb9ab rd389 replied to the topic "Accepting job based on company." - https://medicaldevicecourses.com/activity/p/13469/ Wed, 15 May 2019 17:05:09 -0400 This is my third position, and not have I ever looked up the type of company it is. I dont think personally it matters to me because what matters is the position and what kind of work I am going…   Read more»

]]> 7712f8daaaac023153bd97e9eee521e7 rd389 replied to the topic "What are some ways Document Control can improve?" - https://medicaldevicecourses.com/activity/p/13279/ Wed, 15 May 2019 17:03:33 -0400 Document control will be easier for QA and R&D department if documents that need to be filled out, are entered without any error or miss information or mainly without any false information. Working on research and documenting at the same…   Read more»

]]> d3559a70c330c25609292a942fe5f0e7 rd389 replied to the topic "Good Quality Control or Quality Assurance Department" - https://medicaldevicecourses.com/activity/p/13278/ Wed, 15 May 2019 17:03:33 -0400 I work in R&D department, I haven’t had any issues with QA/QC department. I have worked as a QA before and I did not experience issues with the developer team. Everything I reported was resolved on time. At my current…   Read more»

]]> b889395c341abfd09ab63ab07fcc1dcb rd389 replied to the topic "Discussion Topic: The cost of Quality" - https://medicaldevicecourses.com/activity/p/13275/ Wed, 15 May 2019 17:03:30 -0400 Considering ‘quality is a burden’ is one of the most common mistake of people. Most of the time people in R&D wants product to get qualify and out of the door ASAP. Which makes sense, since they have worked absolutely…   Read more»

]]> 29f85166f8b7b7c3c40879443043b92b rd389 replied to the topic "Relation of Quality with other department." - https://medicaldevicecourses.com/activity/p/13270/ Wed, 15 May 2019 17:03:27 -0400 I think if every department follows rules and regulations then there should not be any conflict. ALthough, this is not possible in real world because there will be something or other that will go wrong either in data or device…   Read more»

]]> 2ee7335c58ad57679e3549fcbe1a16d1 rd389 replied to the topic "FDA rules too strict?" - https://medicaldevicecourses.com/activity/p/13216/ Wed, 15 May 2019 17:02:59 -0400 I don’t think FDA is too strict in approval the medical device or drugs. There are way too many side effects later in life which might not be visible at the time of the inventions. Checking every meticulous detail, and…   Read more»

]]> 7d33950b0717ece7877496d2931a87a1 rd389 replied to the topic "Precision and Accuracy" - https://medicaldevicecourses.com/activity/p/13213/ Wed, 15 May 2019 17:02:57 -0400 Accuracy and precision play important role when it comes to FDA and their rules and regulations. I think they main reason they are important is to make sure any medical device is consistent and there is no adverse effect on…   Read more»

]]> c83754beb4f2bb188f885d90299405ca rd389 replied to the topic "Failure's of Pre-Clinical / Clinical Research" - https://medicaldevicecourses.com/activity/p/13061/ Wed, 15 May 2019 17:01:37 -0400 1. Why was a need to overdose animals? 2. What measures were taken to avoid future overdosing to animals? 3. How were the dead animals disposed? 4. Any care was taken during disposing, considering bio hazards? Sorry to reply to…   Read more»

]]> 7cb1efb0cb3bc582b2de419a2d6dd5a6 rd389 replied to the topic "Discussion Topic: Beyond experimental design issues" - https://medicaldevicecourses.com/activity/p/13003/ Wed, 15 May 2019 17:01:09 -0400 I think the most important precaution would be shipping of those samples and making sure that there is stability of those samples after whatever time it takes to travel. Also, I think it would be also necessary to check before…   Read more»

]]> 8d724e42a4e55afc4275a0d178544098 rd389 replied to the topic "Failure's of Pre-Clinical / Clinical Research" - https://medicaldevicecourses.com/activity/p/13002/ Wed, 15 May 2019 17:01:09 -0400 As being a Bioanalytical scientist, I deal with a lot of clinical and pre-clinical studies. My biggest disappointments are when other scientists overdose animals and research are been called off. One time, they inadvertently overdosed monkeys and after testing 580…   Read more»

]]> c1abbb7cadd76ee6dd45525f654b4948 rd389 replied to the topic "Research for the Fututre or Now?" - https://medicaldevicecourses.com/activity/p/13001/ Wed, 15 May 2019 17:01:08 -0400 I would rather research in which i get result right away and make tons of money. But after done that, I would definitely do research for future generations too. I know i would prob never going to get credit for…   Read more»

]]> da7390446bb6496bd0159f3e82dd7a2e rd389 replied to the topic "Multiple Project Managers for one project" - https://medicaldevicecourses.com/activity/p/12894/ Wed, 15 May 2019 17:00:03 -0400 I have worked on a projects where there were multiple managers and projects where there were sole project manager. Honestly, I liked working under one project manager because there are usually conflicts among project managers and people like me who…   Read more»

]]> 7f67eb792fdda99168df57919d17a8ef rd389 replied to the topic "Obstacles while working on a project" - https://medicaldevicecourses.com/activity/p/12893/ Wed, 15 May 2019 17:00:02 -0400 I have been working as Bioanalytical scientist and my biggest obstacle is things expiring and wasting my time on preparing solutions or reagents for samples I am suppose to extract. So far in my career I have learned to check…   Read more»

]]> 177d57cb8fcb119fd41fa9e97424b9ee rd389 replied to the topic "Milestones Missed: Failure or Success?" - https://medicaldevicecourses.com/activity/p/12891/ Wed, 15 May 2019 17:00:01 -0400 I would say depends but I would also tend towards failure. Working in industry, I have learned you cannot miss a deadline. I have worked 11-12 hours and weekend to make sure the deadlines are met. According to me, missing…   Read more»

]]> 08e6f8f55145e04968f7a601ae56d849 rd389 replied to the topic "Project Manager Experiences" - https://medicaldevicecourses.com/activity/p/12890/ Wed, 15 May 2019 17:00:01 -0400 For my first job, I had two managers and they both had very different personality. One was very old school and he wanted things to be only certain way. More like its his way or highway. While second one was…   Read more»

]]> 8fffe4a4e7baad2e052eb6f905cd8638 rd389 replied to the topic "Advice for Biomedical Engineering Students" - https://medicaldevicecourses.com/activity/p/12637/ Wed, 15 May 2019 16:57:47 -0400 I have never worked as Biomedical Engineer student, but if one advice I have to give I would certainly say to make contacts. Take as many co-ops/paid or unpaid internships and build connections. I am not saying GPA is not…   Read more»

]]> 751a19957818b2f9c560f11f2f2251ab rd389 replied to the topic "Discussion Topic: Practical vs. Informational courses" - https://medicaldevicecourses.com/activity/p/12636/ Wed, 15 May 2019 16:57:47 -0400 I never used theory version of my academia in my practical/industry life. So I always feel that I wasted a lot of money for something that was not beneficial to me. I highly feel that academia to practical ratio should…   Read more»

]]> 12efccbbc3ec913033ab3157cca81b47 rd389 replied to the topic "Discussion Topic: Academia vs. Industry" - https://medicaldevicecourses.com/activity/p/12635/ Wed, 15 May 2019 16:57:46 -0400 I conferred bachelors in biotechnology and mathematics and I got a job as Bioanalytical scientist. It is been 4 years since i have been working in industry and I love it. I love working in industry but definitely NOT as…   Read more»

]]> 181e64287313bb9a425d57a19faa30b8 rd389 posted a new topic "CRO or Big Pharma" - https://medicaldevicecourses.com/activity/p/10584/ Wed, 15 May 2019 16:34:44 -0400 I always wonder where people like to work more or what they would opt for: Small CRO or Big Pharma? Personally, I have worked at both but given a choice I would definitely choose CRO since it is a small…   Read more»

]]> ef5e8f48b27c611ebffea3319481779e rd389 posted a new topic "Drugs banned in US but not in other countries" - https://medicaldevicecourses.com/activity/p/10553/ Wed, 15 May 2019 16:34:30 -0400 DO you guys know any drugs that are banned in US but not in Europe or other countries? And if yes, why was drug banned in USA but not in other countries? Example: Cerivastatin is one of the drug that…   Read more»

]]> 38d30843c289cdddbbd530737a3d39d6 rd389 replied to the topic Factors to consider when executing the NDA in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5556/ Mon, 11 Dec 2017 02:09:20 -0500 When you go to work for a company that requires you to sign an NDA, or you are a company looking to hire employees under a nondisclosure agreement, you will generally see at least five basic elements in the nondisclosure agreement. These are:

1. The definition of “confidential information” that the NDA deals with;
2. Any exclusions from the…[Read more]

]]> 0 02083d80bcd0374038e7b8b795c7dce0 rd389 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5555/ Mon, 11 Dec 2017 02:02:46 -0500 The best thing about this course is that it gives us (students) the practical feeling and more understanding about the industry and how it works. Rather than other courses, it gives us opportunity to work in a team and how to cope/deal with other people of different department. It also teaches to maintain the patience in order to work with them.…[Read more]

]]> 0 bf92341a58c4653ddaf747389fb7d710 rd389 replied to the topic Restrictions for physician's gifts in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5554/ Mon, 11 Dec 2017 01:53:25 -0500 I think that is little absurd that physician’s wife meal is not getting paid off. But then again why is physician’s wife in the meeting? I mean usually these meetings are highly confidential so personally I don’t understand the whole point of bringing your spouse to the meeting. Also, I do understand that gifts should be of certain amount only,…[Read more]

]]> 0 8af6b02d235987c15c8cc953940d2b6a rd389 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5553/ Mon, 11 Dec 2017 01:48:31 -0500 The main difference is that written can be proven in court while oral might be little harder to do so unless you have a witness. Even then it might be tough. I don’t think it is wise to start up a business venture with oral or verbal agreement.

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