https://medicaldevicecourses.com/members/maniakberk/activity/ Activity feed for maniakberk. Fri, 24 Apr 2026 17:20:38 -0400 https://buddypress.org/?v= en-US 30 hourly 2 5fdb6f8e87661faec74f305f2481acd1 https://medicaldevicecourses.com/activity/p/21065/ Mon, 30 Nov 2020 03:12:15 -0500 Sunshine laws are regulations created to deal with these kinds of conflicts. In most basic, it requires business in multiple different industries and businesses, such as the health industry, to make their certain operations transparent and available to the public….   Read more»

]]> fbe32537bf08a907c997c4c91a3df41f https://medicaldevicecourses.com/activity/p/21064/ Mon, 30 Nov 2020 03:02:42 -0500 Personally, I have never been offered such an agreement, but I do know of them. In most basic terms, these agreements are to fire employees without any legal issues. Most companies have huge legal departments who professionalize in these contracts…   Read more»

]]> a73bb648992e5fb94b9cba5092379f5d https://medicaldevicecourses.com/activity/p/21063/ Mon, 30 Nov 2020 02:52:59 -0500 The best advice would be to READ AND UNDERSTAND the document FULLY. Furthermore, the language must be precise and to the point so that no secondary meaning could be understated. Any secondary or hidden meaning can penetrate the legal protection…   Read more»

]]> 5b1c3c1102faddb0575d14cba79b98b2 https://medicaldevicecourses.com/activity/p/21062/ Mon, 30 Nov 2020 02:45:28 -0500 NDA or Non-Disclosure Agreement is simply a contract. If that contract is violated in any way, there is a chance to sue the one who violated the contract. They are not bulletproof, but they can offer some protection against some…   Read more»

]]> 70df3d566bacf3658d8c6cbe6a53bdde https://medicaldevicecourses.com/activity/p/21014/ Mon, 23 Nov 2020 04:38:28 -0500 Posted by: @dbonanno1 Something that is related to this lecture that was not talked about is a “Non Compete Agreement”. Usually bigger companies will make you sign a non compete agreement before you start working there which would prohibit you…   Read more»

]]> 82013caa2d15267abb56d8d133c383a1 https://medicaldevicecourses.com/activity/p/21012/ Mon, 23 Nov 2020 04:23:59 -0500 Posted by: @kbs27 Hi all, In the video lecture Dr.Simon mentioned about two terms of contract,Written & Verbal agreement. He said that verbal contract can be legal but what if the due to dispute or other reason the verbal agreement…   Read more»

]]> 58f421fc6dfe97e757a6aba580a23cf2 https://medicaldevicecourses.com/activity/p/21010/ Mon, 23 Nov 2020 04:15:48 -0500 There are a lot of consultants in the medical device industry. N most basic, they all have a deep understanding of ISO9001 and ISO 13485. Not every medical device consultant can work with every device, though. They usually specialize in…   Read more»

]]> bcd2f5511a44f9a8612dccd06194ec05 https://medicaldevicecourses.com/activity/p/20903/ Sun, 15 Nov 2020 04:38:52 -0500 Posted by: @jp582 As Dr. Simon has mentioned in this week video lecture, method to analyze risks and one of the method he talked about is Failure Mode, Effects, and Criticality Analysis (FMECA). FMECA is potentially utilized for failure and…   Read more»

]]> c42d14943681ddf08dac4aa1cc83fde4 https://medicaldevicecourses.com/activity/p/20902/ Sun, 15 Nov 2020 04:11:49 -0500 Dealing with risk, there are certain steps to follow. To start with, a risk register must be created. A risk register is basically a spreadsheet that includes areas to put information about the description of the risks, the likelihood of…   Read more»

]]> 12238101b79a5f03b87c3e3dd9139a50 https://medicaldevicecourses.com/activity/p/20901/ Sun, 15 Nov 2020 03:40:40 -0500 Posted by: @dyc6 Another factor contributing to risk values is the percentage of false-positives or false negatives, particularly for diagnostic devices. For example, if a patient is scanned (with X-ray, MRI, ultrasound, etc.) and the result is actually a false…   Read more»

]]> 05ec50a458e141cd9ecbcb7b705ed460 https://medicaldevicecourses.com/activity/p/20836/ Sun, 08 Nov 2020 16:56:06 -0500 To start with, DDP stands for design and development plans. DDP aims to describe the product or design to create a chart of its production cycle, marketing, and company procedures and regulations. In my view, a person who needs to…   Read more»

]]> f8d776308175721e44aba1e431bdfc60 https://medicaldevicecourses.com/activity/p/20835/ Sun, 08 Nov 2020 16:44:24 -0500 Posted by: @rgp29 Hello everyone, I have noticed how Dr. Simon keeps pointing out to importance of taking minutes in all the meeting of the team. I never really thought of how important they are. Before this, when I was…   Read more»

]]> 87ad8cb10ffa8243e0e540f9ac7fc982 https://medicaldevicecourses.com/activity/p/20834/ Sun, 08 Nov 2020 16:36:55 -0500 Posted by: @savery115 Statistical sampling is required for design verification and validations. If you have worked for a company or written protocols in the past – how have you explained or ensured that the sampling plan and statistical approach you…   Read more»

]]> d630bea0eb6aa542434f7a59b87e6b2e https://medicaldevicecourses.com/activity/p/20784/ Mon, 02 Nov 2020 01:06:34 -0500 There are various things that the FDA will be looking for in a Design Contol System. (1)Design and development planning. (2)Design input: It has information about the intended use and sure needs. (3)Design output: It tells if the output meets…   Read more»

]]> e435662f135a1203490560031e59a054 https://medicaldevicecourses.com/activity/p/20782/ Mon, 02 Nov 2020 00:50:00 -0500 The design control process in Turkey is done by the Turkish Medicines and Medical Devices Agency. It follows ISO 13485 and ISO 9001. For Turkey, medical devices must have CE markings and must be registered in the Turkish Ministry’s Online…   Read more»

]]> 0e5f4898aea15d8d44043ca0d6ad0e07 https://medicaldevicecourses.com/activity/p/20780/ Mon, 02 Nov 2020 00:32:10 -0500 There are many constraints in the development of medical products and devices. Identification of these constraints is important, and there is a procedure to follow named design controls. For medical devices, design control is needed from the Food and Drug…   Read more»

]]> 4ccff15ec501195506d5ba863e357e02 https://medicaldevicecourses.com/activity/p/20721/ Mon, 26 Oct 2020 02:06:17 -0400 Posted by: @amandaally1029 With clinical studies comes lots of risks, especially where human participants are concerned. However, in order to figure out if a medical product, device, or drug is essential, these studies are necessary. What do you think are…   Read more»

]]> 59b31c462833f1c578d8b5ec8c753b3c https://medicaldevicecourses.com/activity/p/20720/ Mon, 26 Oct 2020 01:55:51 -0400 Posted by: @merzkrashed As Dr.Simon mentioned about placebo-controlled trials, which is A “dummy” device or drug is used on one group of patients and compared to patients with the real one, or sometimes called a ‘sugar pill. Or a fake…   Read more»

]]> ada7dfd8e51932a3c962283116e76518 https://medicaldevicecourses.com/activity/p/20713/ Sun, 25 Oct 2020 17:37:56 -0400 Posted by: @sam-doksh Clinical research is a is the study of health , it is important for the progress of modern medicine. It determine the safety and efficacy of medications, devices, and treatment regimens intended for human use.    …   Read more»

]]> dc8f628366efecc671bd4ca62c626065 https://medicaldevicecourses.com/activity/p/20670/ Mon, 19 Oct 2020 01:10:07 -0400 When I first read the title ”Sales vs. project management”, it didn’t make any sense to me, but as I thought about it, although it may not be obvious, project management is crucial for effective sales. The consumer themselves have…   Read more»

]]> 3eed49ba7973c54cdd8cee9387a6230e https://medicaldevicecourses.com/activity/p/20669/ Mon, 19 Oct 2020 00:50:39 -0400 Kidwell et al. talk about Emotional Intelligence in marketing is a crucial fact. In the paper, it is suggested that Emotional Intelligence is a key factor in sales performance. Sales performance is basically defined with Customer Retention and Sales Revenue….   Read more»

]]> 5f38144a6b6bec8e356eb94b237f2e95 https://medicaldevicecourses.com/activity/p/20666/ Mon, 19 Oct 2020 00:32:33 -0400 To start with, marketing and sales are two different things, but we can call them 2 different sides of the same coin. Sales are, as the name suggests, include the activities of selling products and/or services. On the other hand,…   Read more»

]]> 34d1ef18cb1ebb744d0e16c69fddc31c https://medicaldevicecourses.com/activity/p/20613/ Mon, 12 Oct 2020 13:37:16 -0400 It must be different for every company and every individual, but my experiences tell me don’t ever do business with your family and try to avid family-owned businesses altogether. Family-owned companies tend to create unfair ranks within the working force….   Read more»

]]> 7e196904a6e215122a22cb99d45bdf93 https://medicaldevicecourses.com/activity/p/20612/ Mon, 12 Oct 2020 13:30:12 -0400 After some bad experiences I had, I would say YES! Accepting the job based on the company is crucial. Just because the other company gives you a few amounts of extra money shouldn’t be the reason for your decision. In…   Read more»

]]> 452c64d89442f58ceb4722ef02400154 https://medicaldevicecourses.com/activity/p/20611/ Mon, 12 Oct 2020 13:17:53 -0400 Personally, I never worked in public yet but according to all I had read tells me, the benefits and job security are a lot better than private jobs in general. A lot of people won’t choose it though. Most of…   Read more»

]]> ae16b5f07f6b1117d796efece351a0da https://medicaldevicecourses.com/activity/p/20549/ Mon, 05 Oct 2020 03:12:56 -0400 There are a lot of different businesses in different industries and although they might have similar Quality Assurance processes is highly unlikely that they will have the same quality assurance process. I know some of the emerging technologies and methods…   Read more»

]]> dbf596f64931aeff632af34563ddc74e https://medicaldevicecourses.com/activity/p/20548/ Mon, 05 Oct 2020 02:49:47 -0400 Ethics and corruption is a problem and business, and in terms of Quality Control and Quality Assurance, it is no different. Superficial language differences can create an opportunity to create an ethics problem while everything is okay on the paper….   Read more»

]]> b4c3c50a4ef315301efea54f000d7772 https://medicaldevicecourses.com/activity/p/20541/ Mon, 05 Oct 2020 01:16:57 -0400 I have a related question about this too. This is a question that my friend faces with his job. He is a biomedical engineer who works as a quality control person in a medical firm. He has almost two years…   Read more»

]]> 5f887dad8a6945613ff9c5b384706125 https://medicaldevicecourses.com/activity/p/20481/ Mon, 28 Sep 2020 03:36:17 -0400 Posted by: @orleron This is always a fun module for discussion topics because there’s always some modern technology out there that challenges the current regulatory framework. Today… e-cigarettes. If you don’t know what one is, google it. Does the FDA…   Read more»

]]> 69c7e989c83f2894f5fce23b35583419 https://medicaldevicecourses.com/activity/p/20480/ Mon, 28 Sep 2020 03:26:27 -0400 Posted by: @smitshah I was wondering that why are the recall either made by company or made my FDA are of items which have been in the market for at least 5-8 years after the launch in market. Why cant…   Read more»

]]> 4dfa887459f171a83f4fe457a8446fb7 https://medicaldevicecourses.com/activity/p/20478/ Mon, 28 Sep 2020 03:20:26 -0400 Posted by: @rd389 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…   Read more»

]]> 068429b2242a9e79cd853abff476c0fb https://medicaldevicecourses.com/activity/p/20475/ Mon, 28 Sep 2020 03:06:27 -0400 Posted by: @orleron Explain the difference between QA and QC, and think about the differences that each of these have as a career.  For example: What types of training are relevant to each and how could they differ? What types…   Read more»

]]> 9bfb817e8ef1ad0c7328406cf3af50ee https://medicaldevicecourses.com/activity/p/20473/ Mon, 28 Sep 2020 02:50:00 -0400 Posted by: @smitshah From the lecture as we saw that major work of quality department is to oversee if all other department have abide to procedure which are set by regulatory boards in order to get certified and if a…   Read more»

]]> ff0cb76f54b46c944fa902e733b1723c https://medicaldevicecourses.com/activity/p/20470/ Mon, 28 Sep 2020 02:41:47 -0400 There are steps to follow. 1)  Building an effective process. The quality control process must start by creating a checklist that covers everything. This checklist must be made by a seasoned employee rather than a new employee. Also, it should…   Read more»

]]> bfa45ead76f121ea939d14587c6c6b58 https://medicaldevicecourses.com/activity/p/20398/ Mon, 21 Sep 2020 01:14:49 -0400 Posted by: @dyc6 From a project management standpoint, one factor I would look for in a biomaterial is how outdated the material is. Although previous posts have mentioned that using new biomaterials may be risky, I think the opposite side…   Read more»

]]> f9a05338dbb5a17dd7cceea036a569ef https://medicaldevicecourses.com/activity/p/20397/ Mon, 21 Sep 2020 00:47:20 -0400 I prefer doing research for a living than doing engineering work for a living, especially when I become old, it will be more comfortable to use my brain rather than my muscles. But in my view, to be able to…   Read more»

]]> 7d48c4313b5c710b68fa7d90bb796041 https://medicaldevicecourses.com/activity/p/20395/ Mon, 21 Sep 2020 00:29:20 -0400 I feel more comfortable doing research for a living than doing engineering work for a living. There are two options, either academia or industry. Although I would be more comfortable and more efficient doing research, I want to make a…   Read more»

]]> 8917ff2ee5874716f2389150af921c92 https://medicaldevicecourses.com/activity/p/20394/ Mon, 21 Sep 2020 00:26:13 -0400 I feel more comfortable doing research for a living than doing engineering work for a living. There are two options, either academia or industry. Although I would be more comfortable and more efficient doing research, I want to make a…   Read more»

]]> 14a9ab3aad2f9327d0133312c5d733d6 https://medicaldevicecourses.com/activity/p/20305/ Sun, 13 Sep 2020 23:20:37 -0400 So a Project Manager(PM) position is something I wanted to have over the years but I was never accepted to any of my applications as an employee. So my question is that what a person can do to become a…   Read more»

]]> b48436c486a61d97f61c4c2c03f0119f https://medicaldevicecourses.com/activity/p/20304/ Sun, 13 Sep 2020 23:13:04 -0400 Posted by: @bb254 Give an example of a time when you encountered an obstacle while working on a project that could have resulted in not reaching the deadline.What phase of the project life cycle should you have focused on more…   Read more»

]]> 4b86fc84ebccc25ebe97488f245da7e9 https://medicaldevicecourses.com/activity/p/20303/ Sun, 13 Sep 2020 23:05:22 -0400 Posted by: @bb254 This week’s lecture discusses the different phases within a project life cycle; initiating, planning, executing, monitoring & controlling and closing phase.Which phase of the project life cycle do you think is crucial to the success of a…   Read more»

]]> d0f80ef44318c70f6acb6938e7c5a6c5 https://medicaldevicecourses.com/activity/p/20223/ Sun, 06 Sep 2020 05:10:39 -0400 Posted by: @bb254 For those who have work experience in the medical device industry, what advice would you give to Biomedical Engineering students? What would you have wished you would have done differently as a student to help project your…   Read more»

]]> f3db211afd57d791827e3f2f632c06bb https://medicaldevicecourses.com/activity/p/20220/ Sun, 06 Sep 2020 03:01:13 -0400 Posted by: @karen-immanuel Hello all, I was just curious as to what level of education is best before getting into industry. My thoughts are that BS is good enough to employ you with basic skills and knowledge. Later, you can…   Read more»

]]> bcc3aabd5f6f7ce7be7ad014e1e64841 https://medicaldevicecourses.com/activity/p/20218/ Sun, 06 Sep 2020 02:46:12 -0400 Biomedical Engineering education is an education that doesn’t teach you anything about marketable skills. Those professions are created for Electrical engineers, Computer engineers, etc. Unlike Other majors, BME is a combination of various majors, and although this won’t make you…   Read more»

]]> c920192a640dcf405cfa09655729ba53 https://medicaldevicecourses.com/activity/p/20217/ Sun, 06 Sep 2020 01:58:56 -0400 Biomedical Engineering education is an education that doesn’t teach you anything about marketable skills. Those professions are created for Electrical engineers, Computer engineers, etc. Unlike Other majors, BME is a combination of various different majors, and although this won’t make…   Read more»

]]> 758755ba6c85842d040ed8a38f7885aa https://medicaldevicecourses.com/activity/p/20216/ Sun, 06 Sep 2020 01:53:34 -0400 Posted by: @orleron This week is an overall introduction to the field of medical device development. We take some time to pay attention to the differences between Academia and Industry (Commercial) because students in this course may come from one…   Read more»

]]> acd39909e9c0733bb6998793d107375f https://medicaldevicecourses.com/activity/p/20215/ Sun, 06 Sep 2020 01:33:21 -0400 9810dc5ac43e829fbec134905ce8cd9f https://medicaldevicecourses.com/activity/p/20212/ Sat, 05 Sep 2020 23:04:00 -0400 0