https://medicaldevicecourses.com/members/sallirab/activity/ Activity feed for SalliRab. Fri, 24 Apr 2026 16:55:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 d317b2ac3739016c27bba0a95757db14 https://medicaldevicecourses.com/activity/p/21036/ Thu, 26 Nov 2020 04:31:20 -0500 Companies should always have their employers and vendors sign a non-compete agreement and a non-disclosure contract. Some of the trade secrets limitation to be considered is that it can be patented by others, and it is not easily enforceable.

]]> 46a85fee801a52aded6a5d40e5d26dcf https://medicaldevicecourses.com/activity/p/21035/ Thu, 26 Nov 2020 04:07:24 -0500 One important thing to be aware of, especially when dealing with companies from other counties, is to understand how there system works treating the NDA . Always clarify which jurisdiction you wish to apply to the agreement.

]]> b9ecbfe2fca7ff0342fc2f0c55be997d https://medicaldevicecourses.com/activity/p/21034/ Thu, 26 Nov 2020 03:00:34 -0500 Having this rule is really helpful, as the physician will not make the judgment about the device according to what the company has offered from gifts, so the process will be fair to all companies if it was a big…   Read more»

]]> 8efc50dd65772ff105ef58251121b5d6 https://medicaldevicecourses.com/activity/p/21033/ Thu, 26 Nov 2020 02:41:12 -0500 487a6086468f849f239aa8f7dc9f1562 https://medicaldevicecourses.com/activity/p/20969/ Fri, 20 Nov 2020 19:36:50 -0500 After the team has meet, we did brainstorming for getting all DID inputs and even Risks, Our PM did the planing and the timeline and we are working to get everything done according to the Gantt chart. I am happy…   Read more»

]]> a8c512672237359f72d4881ea24a87ee https://medicaldevicecourses.com/activity/p/20968/ Fri, 20 Nov 2020 19:07:11 -0500 I am currently working in a functional organization outside of the biomedical field.  I would like to work i a matrix organization because that can let me gain different experience working in different type of projects and also more soft…   Read more»

]]> bcf9af020f8eb604c745b63345363849 https://medicaldevicecourses.com/activity/p/20967/ Fri, 20 Nov 2020 18:42:11 -0500 Having a  knowledgeable team members with a good relation is the best combination. With there knowledge in there department will help them understand there roles and what they need to deliver on what time and having a good (Friendly) relation…   Read more»

]]> 2bfd8b0470c2576fdf18904e817d9b3d https://medicaldevicecourses.com/activity/p/20892/ Fri, 13 Nov 2020 21:16:59 -0500 In addition to what the others have said,  Pareto diagram is a great way to identify which problems should be prioritized based on the cumulative effect it has on a system. While the length of the bars represents the frequency…   Read more»

]]> 6f9120cc43d34a61e73643e93a8021bd https://medicaldevicecourses.com/activity/p/20891/ Fri, 13 Nov 2020 21:05:13 -0500 As we all know, X-ray devices have a lot of risks if the person was expose to high radiation levels, but having the X-ray was huge deal in the medical history. Some risks we need to accept for the greater…   Read more»

]]> 6812d292d7fe51e20b15aaf00fa496fc https://medicaldevicecourses.com/activity/p/20890/ Fri, 13 Nov 2020 20:54:22 -0500 bbe4459dabe73c36b4550790a4608091 https://medicaldevicecourses.com/activity/p/20889/ Fri, 13 Nov 2020 20:53:20 -0500 Post-market surveillance is important because it reveals more about product safety and effectiveness that could not be learned during clinical trials. It also monitor products’ performance in the field, detecting product faults, and help initiating necessary measures such as recalls…   Read more»

]]> 56d764af845f3684c35bfadd98590fe9 https://medicaldevicecourses.com/activity/p/20826/ Sat, 07 Nov 2020 01:21:12 -0500 84d639decc005ff4e34f7ce1825ee261 https://medicaldevicecourses.com/activity/p/20825/ Sat, 07 Nov 2020 01:14:57 -0500 One of the most important thing to have deign controls is to reduce the products recall and to save more humans. It also to assure that devices meet user needs, intended uses, and specified requirements by giving more attention to…   Read more»

]]> 5bb2a17fa1a351f5c54c5748353847a0 https://medicaldevicecourses.com/activity/p/20824/ Sat, 07 Nov 2020 01:00:48 -0500 As it have been stated by the others, DID is a document that contain the inputs data from the customer (users) but it also have different inputs such as Functional, environmental, physical , labeling and regulatory input. During the project…   Read more»

]]> 9cecbf16a2fee5de0c25f310ffe22bb8 https://medicaldevicecourses.com/activity/p/20787/ Mon, 02 Nov 2020 01:31:04 -0500 Abbott Cell-Dyn (CBC instruments) verification protocol should have to test the amount of blood the syringe take in from the tube in both open and closed mode, the time it take to give the results, the shear valve segmentation of…   Read more»

]]> a74ded3e20b054a55dd4f83ded2814ba https://medicaldevicecourses.com/activity/p/20786/ Mon, 02 Nov 2020 01:21:24 -0500 I did a search about Jordan regulation and i really found it interesting. As it is a small country, i did not found anything about development of medical devices, but all the regulation are based on device coming from other…   Read more»

]]> 988428123d469be53f2786753176ed92 https://medicaldevicecourses.com/activity/p/20783/ Mon, 02 Nov 2020 01:00:36 -0500 All the 9 are very important, but you can still find projects done without some of them. – Planning should have breakdown of tasks alongside the people/team responsible for them, a Gantt chart is the best example for it. -…   Read more»

]]> 82c00afdcf7739571a48f4df26ef21ae https://medicaldevicecourses.com/activity/p/20719/ Sun, 25 Oct 2020 22:17:33 -0400 Randomization and blinding are considered to be characters of best study design, but the “Gold Standard” Clinical trial are Randomized double blind placebo control. It eliminate the influence of  immeasurable variables that may lead to biased and incorrect estimate of…   Read more»

]]> 0fc0159b846cb6786e77b16f6815ecf2 https://medicaldevicecourses.com/activity/p/20718/ Sun, 25 Oct 2020 21:54:33 -0400 one thing to add is clinical trails for drugs takes at least 10 years to develop new medicine. It take a lot o time for development and getting FDA for approval. I have red and i am quoting “Less than…   Read more»

]]> e6ceb3e4fbc2e6397d54991f8f9f1a97 https://medicaldevicecourses.com/activity/p/20696/ Fri, 23 Oct 2020 00:53:19 -0400 As have been said before there is different Pros and cons for clinical studies, one of the cons that come up to my mind is long term side effect. Some side effects appears several years later even after clinical trials…   Read more»

]]> 9980ef1fa0cf86e17e04c0648cbe1bd4 https://medicaldevicecourses.com/activity/p/20689/ Wed, 21 Oct 2020 20:26:22 -0400 4607c1fd4d3b40375316e5f01de82692 https://medicaldevicecourses.com/activity/p/20619/ Thu, 15 Oct 2020 22:38:27 -0400 Having conferences is a great way for marketing and per-launch, one great way i experienced was having the showcase for the product using VR which was fun to use and to interact with. On bad side that happened,the laboratory device…   Read more»

]]> 6764efc5322f364a357f816ee6459c3b https://medicaldevicecourses.com/activity/p/20618/ Thu, 15 Oct 2020 22:11:13 -0400 Sales and product management play a complementary role, where if there is no sales that mean no business, no business = no cash and the company is out of the game. Sam Walton once said ” there is only one…   Read more»

]]> ca3878e66a39dbd936119b64f51286b3 https://medicaldevicecourses.com/activity/p/20617/ Thu, 15 Oct 2020 21:34:46 -0400 I am not a fan of all type of advertisement, but the ones that i might like are the ones that had a nice music, real example that happened, while  I am driving I had YouTube play my list of…   Read more»

]]> 8c0a4da1ba4651f5ef0b3f71802f361a https://medicaldevicecourses.com/activity/p/20601/ Mon, 12 Oct 2020 02:46:50 -0400 I choice Apple(Jun-30-2020) Gross Profit margin: 38.19% this number considered low as it is the amount of money the company make after spending a certain money. Net profit margin: 21.33% which is almost the same as (with small difference) from…   Read more»

]]> f69417883dbed80e6a2b6d80ce544815 https://medicaldevicecourses.com/activity/p/20599/ Mon, 12 Oct 2020 01:58:11 -0400 I would consider doing a partnership. Having someone with the same vision and passion for the dream we want to achieve. It is a great adventure to start the life with, but i don think i will consider it as…   Read more»

]]> 2fa11baf27e504badb67fd9426083420 https://medicaldevicecourses.com/activity/p/20598/ Mon, 12 Oct 2020 01:38:01 -0400 Ratio importance depends on the company type (what they do) , it gives indications about the health of the business and how it is growing. for example, doing an inventory turns for barbershop business make no seance. Bad ratio can…   Read more»

]]> b271f15f62e92ed9a83b4844011f1c29 https://medicaldevicecourses.com/activity/p/20518/ Fri, 02 Oct 2020 23:17:56 -0400 I agree, ethics and QA are related and you can see this in any type of environment. One of things a always notice, the drive force for people to follow the rules (QA system) comes from fear “what happen if…   Read more»

]]> 62181c98080bc99e5f15a47dd8a1232a https://medicaldevicecourses.com/activity/p/20517/ Fri, 02 Oct 2020 23:00:12 -0400 QA is derived from FDA and ISO regulation and the company Vision. QA Team should keep an eye around what is happening in the world and what going on inside the company. Communication always help improvement with feedback in the…   Read more»

]]> f28a3ff1f441247fbbef24eba77f49b8 https://medicaldevicecourses.com/activity/p/20516/ Fri, 02 Oct 2020 22:28:45 -0400 I also agree that this game – unfortunately – exists in  the world, and as it have been said, it is human nature. I do not think there is any cure for this situation, humans have different personality. You have…   Read more»

]]> 23d3321625a3b4360fec72ab89fafc42 https://medicaldevicecourses.com/activity/p/20463/ Sun, 27 Sep 2020 21:48:20 -0400 Sirolimus Eluting Coronary Stent. This device is indicated for improving coronary luminal in patients.The mode of Action for this device is a drug elutingballoon- expandable stent that is pre-mounted on PTCA catheter delivery system. It falls under CDRH and considered…   Read more»

]]> 0cb2dde88da087a9321f18baf40e03f3 https://medicaldevicecourses.com/activity/p/20462/ Sun, 27 Sep 2020 20:16:19 -0400 productivity might get negatively effected with having people from different cultural background. For example having different holidays, which might effect the project timeline. But other thank that from my experience it helped more as people have different experiences and can…   Read more»

]]> d4b1d5b36352c135f759fb8e6c0baddb https://medicaldevicecourses.com/activity/p/20457/ Sun, 27 Sep 2020 18:57:31 -0400 let’s make the question as, what does it mean to have an imprecise  and inaccurate medical device? The answer would be, that would not consider a medical device, it can count as a broken device. If the device does not…   Read more»

]]> 47421d7cbe17709d856559212dd47049 https://medicaldevicecourses.com/activity/p/20363/ Sat, 19 Sep 2020 22:46:14 -0400 It is hard to choose one over the other. Seeing the result right away give satisfaction for sure, but doing research that help the next generation might be like predicting the future. In addition, it is hard to state that…   Read more»

]]> fe4819ef5807ee2e0ce96f560fbc94f1 https://medicaldevicecourses.com/activity/p/20362/ Sat, 19 Sep 2020 22:18:55 -0400 Animal testing is needed to reduce the time needed for development, maybe it seems the only possible way but there is different thing that can be done. For me I don’t like it, and i consider it not ethical. Human…   Read more»

]]> 6e96351781a2d18eb0c4c6859ea5f8e9 https://medicaldevicecourses.com/activity/p/20361/ Sat, 19 Sep 2020 21:56:37 -0400 All what have been said make a good points, but for me when talking about project management stand point, the most important part is money, time, and same specs. we all agree that Biomaterials must be compatible with the human…   Read more»

]]> 5d68dead78687daa1f8bc553c7de8dae https://medicaldevicecourses.com/activity/p/20265/ Sat, 12 Sep 2020 01:09:50 -0400 The most challenging part for combination device is to know to what FDA Department it will be classified under (CBER, CDER and CDRH). As each one of these department has it is own rules for reviewing the product. Depending on…   Read more»

]]> 1a1bdd97d10bfd5082baedcedb5b4e91 https://medicaldevicecourses.com/activity/p/20264/ Sat, 12 Sep 2020 00:47:19 -0400 Project Objectives should also be S.M.A.R.T : Specific, Measurable, Achievable, Relevant and Time-Related. To have objectives to the project but the most important part is to get the Right Objectives. Its good to learn from previous projects experiences to build…   Read more»

]]> 2e58f7c27df11c4063dff938e18bf0da https://medicaldevicecourses.com/activity/p/20263/ Sat, 12 Sep 2020 00:35:27 -0400 I agree with what had been said, Good project manager should have a lot of different soft skills with good experience. In my opinion, if a person have 15 years experience in the industry with no leadership or good soft…   Read more»

]]> 638156b62229e414e334fe72e5bb7358 https://medicaldevicecourses.com/activity/p/20162/ Wed, 02 Sep 2020 01:08:28 -0400 My advice, is never stop learning, always keep searching in the field to see what’s going around (don’t leave your self in the dark), even check what skills needed in each Job posted, examin yourself and work on how to…   Read more»

]]> cf7c1d8c951c9eff7941a0b65060b923 https://medicaldevicecourses.com/activity/p/20161/ Wed, 02 Sep 2020 00:53:12 -0400 Students are the main stone in building a nation, my argument for academia is that you can be the role model in changing students life and lead them to be grater than what they Never think of. I believe is…   Read more»

]]> b7730bd716f87ea90a5b10ccf56fd4fe https://medicaldevicecourses.com/activity/p/20160/ Wed, 02 Sep 2020 00:35:51 -0400 I believe there is no right way to do it, my idea is making 2 different programs were the Student can choses the track they are interested in. For my self I am a practical person and I still wish…   Read more»

]]> dd2de6b82378878b51770fb7729dbd01 https://medicaldevicecourses.com/activity/p/20016/ Sun, 03 May 2020 15:42:36 -0400 This course helped me to see the overall picture of how Projects get done. For someone who has no experience in PM and the rules and regulations in the US, I have learned a lot.

]]> 9dcd2e0e93ab0013267a5d9c61844829 https://medicaldevicecourses.com/activity/p/20009/ Fri, 01 May 2020 15:34:27 -0400 the Size shapes how the company works. Having smaller size company means few people in each department which leads how to work with projects and what type of organization (functional, project based, and matrix) they are working with.

]]> 2c96a12724fc3ccdbfd68bcf33c19436 https://medicaldevicecourses.com/activity/p/19955/ Sat, 25 Apr 2020 23:54:35 -0400 There are more things to consider and i believe we can not get any general statement about this in regards all the different personalities. Some of the resons why people would work more than 40 hours are: – They really…   Read more»

]]> b8b62f10175ebc322a09f0525799ffd0 https://medicaldevicecourses.com/activity/p/19954/ Sat, 25 Apr 2020 23:42:28 -0400 After 10-13 years from now I will be a manager, I still do not have the skills and knowledge to be one. I will work as engineer and I would love to search through all possible jobs to see where…   Read more»

]]> 8263bc6655d34dd18282a79bc26e6a03 https://medicaldevicecourses.com/activity/p/19941/ Thu, 23 Apr 2020 19:51:35 -0400 My motivation is when I look 10 years later at the old me I will say I did my best and nothing less than my best, not to regret things and gave it all I can. I like to have…   Read more»

]]> 653e3e107fb2d8f9cbd71ec89ea8cea4 https://medicaldevicecourses.com/activity/p/19937/ Thu, 23 Apr 2020 19:33:36 -0400 I am not surprised, but where i came from ” third world country” money is the main reason why people go to work and stay. This study would have different result if it stated people ages and level of experiences,…   Read more»

]]> a1b606ddea04f3725ed90cdc4ab5fde7 https://medicaldevicecourses.com/activity/p/19886/ Sun, 19 Apr 2020 01:21:02 -0400 5709e8817f178adb6e14f1a65ba46c5b https://medicaldevicecourses.com/activity/p/19885/ Sun, 19 Apr 2020 01:20:59 -0400