https://medicaldevicecourses.com/members/rifath-hasan/activity/ Activity feed for Rifath Hasan. Sat, 16 May 2026 07:44:35 -0400 https://buddypress.org/?v= en-US 30 hourly 2 e68d9c4dee33c87ad112f3985f30898f https://medicaldevicecourses.com/activity/p/24147/ Mon, 06 Dec 2021 15:39:15 -0500 Design control means a specific way of planning and executing medical devices or projects. It’s a combination or sum of laws. There are different parts of the design process. Each part can have detailed documentation or multiple portions can be…   Read more»

]]> 55b24975666d6a40bb2501334172c987 https://medicaldevicecourses.com/activity/p/24146/ Mon, 06 Dec 2021 15:39:14 -0500 In many countries the design control standards are different. While in the US FDA follows ISO code regulations. On the other hand, there are different standards settled by other countries. Though there is a huge geographic and immune difference, most…   Read more»

]]> d821cf8c94c6a963a752b8aba04912fb https://medicaldevicecourses.com/activity/p/24145/ Mon, 06 Dec 2021 15:39:14 -0500 Statistical sampling used in Control Quality. It is defined as selecting part of a population. The samples are chosen and tested according to the quality management plan. When doing this particular project management technique, the sample size and frequency should…   Read more»

]]> 60145229c44d33343563a24f4300cafc https://medicaldevicecourses.com/activity/p/24144/ Mon, 06 Dec 2021 15:38:38 -0500 I completely agree with the statement @cem34 made, though the reasonings are different in my opinion. Validation doesn’t signify real-time functionality rather it ensures the efficacy of a product based on user input. On contrary, verification denotes inspection of a…   Read more»

]]> 26d161016df18044306064ac6ce4ea9c https://medicaldevicecourses.com/activity/p/24143/ Mon, 06 Dec 2021 15:38:38 -0500 “Human factor” plays a crucial role in design verification ethics. Along with verification and validation, there’s a term called Human Factor which means, evaluating a device’s user interface to confirm that the device can be used safely and effectively by…   Read more»

]]> 1d8add599eae14015d82bcd13e14c8a0 https://medicaldevicecourses.com/activity/p/24142/ Mon, 06 Dec 2021 15:38:37 -0500 I would like to talk about the verification protocol imposed by FDA on Surgical masks. Inadequate fluid resistance, Inadequate barrier for bacteria, Inadequate air exchange (differential pressure), Flammability, Inadequate respiratory barrier for bacteria are some of the tests needed to…   Read more»

]]> f10bc47bb7bc4700e72c01cd0e54c338 https://medicaldevicecourses.com/activity/p/24129/ Mon, 06 Dec 2021 15:37:01 -0500 Since there are two types of risks involved, their difference would enable us to solve them. Cost risk, schedule changes, performance and quality risk are listed as internal risks. Cost risk means risks of project costs being exceeded due to…   Read more»

]]> 453829482b8c062e35bb04c9d14e99f2 https://medicaldevicecourses.com/activity/p/24128/ Mon, 06 Dec 2021 15:37:01 -0500 Though risk management certainly has some advantages and benefits, there are some disadvantages too. If we think about automated risk management information systems that will make my statement more clear. It is not suitable for all kinds of organizations. Firstly,…   Read more»

]]> 0b8ece670b6f698b6434656dc888a7c0 https://medicaldevicecourses.com/activity/p/24127/ Mon, 06 Dec 2021 15:37:00 -0500 There are many tools that can be used to mitigate the risks. Some of them are being discussed in risk management lectures. Mainly three tools have been mentioned. Among them first one was FMEA. FMEA stands for failure mode effects…   Read more»

]]> 4865acdab5040e29527406d46c67edd2 https://medicaldevicecourses.com/activity/p/24122/ Mon, 06 Dec 2021 15:36:42 -0500 From the lecture we know, there can be three different types of organizations where tasks are performed in three different ways. Project teams can be formed based on the employee’s skillsets, availability, or compatibility. Though there are certainly some downsides…   Read more»

]]> 60f82a0b9f1a72583b5cb2acc3acf2b1 https://medicaldevicecourses.com/activity/p/24121/ Mon, 06 Dec 2021 15:36:42 -0500 We have known from Dr. Simon’s lecture, upper management is strategic, while middle management is tactical. Upper management is concerned with the growth of organization in the upcoming years, while the middle management people take care of the nitty-gritty things…   Read more»

]]> 5df2cad3b8d4da0cb551a0bfb59f3ed5 https://medicaldevicecourses.com/activity/p/24120/ Mon, 06 Dec 2021 15:36:41 -0500 I do have different opinions than @naglaa. For startup medical device companies I would highly recommend matrix organization over functional and project-based organizations. In functional organizations, there are silos between departments and I believe that harms the performance. Similarly, in…   Read more»

]]> 4cfcefd1785e8b222e3902c6c0ae89fa https://medicaldevicecourses.com/activity/p/24118/ Mon, 06 Dec 2021 15:36:40 -0500 According to me, there are many advantages of written contracts over verbal ones. Some of the reasons are mentioned below:01. A written contract lays out the terms of the agreement which limits any of the parties to  claim anything otherwise.  …   Read more»

]]> 99df26e5b7d20421ec7ca5605be7cb6a https://medicaldevicecourses.com/activity/p/24117/ Mon, 06 Dec 2021 15:36:39 -0500 In this week’s lecture, Dr. Simon mentioned some laws which restrict physicians to receive gifts from companies.  The laws are Anti-kickback Statutes and Advamed Guidelines.  I agree with Naglaa. I am from the same area, where pharmaceutical companies highly influence…   Read more»

]]> 9f16895c4df709c9d2b6c3ec03a60a1f https://medicaldevicecourses.com/activity/p/24116/ Mon, 06 Dec 2021 15:36:38 -0500 Posted by: @jaf22 Consultants in my company or my previous company have been useful in bringing expertise where our group lacks or needs a third party view. For instance, my company had a large acquisition that needed some smoothing of…   Read more»

]]> e19f306a45c5f9efb2a3dadb9f32d4d5 https://medicaldevicecourses.com/activity/p/23880/ Sun, 31 Oct 2021 14:05:57 -0400 Though incentives are offered to attract participants to join clinical trials, candidate selection plays an important role in accomplishing a successful research study. Therefore, picking randomized contestants and performing double-blind procedures will help minimize the selection bias. A double-blind study…   Read more»

]]> 62bd184b0ff969b34ee356294ba9b182 https://medicaldevicecourses.com/activity/p/23879/ Sun, 31 Oct 2021 14:05:56 -0400 Double-blind studies mean neither the experimenter nor the participant has any clue about the study or treatment. That helps to get the best possible results out of the experiment. Since the experimenter is also clueless about who is receiving the…   Read more»

]]> ec144e6348cd0ce5d2890dd40e18cf36 https://medicaldevicecourses.com/activity/p/23878/ Sun, 31 Oct 2021 14:05:56 -0400 Clinical research is significant in determining the safety and effectiveness of medications and medical devices. I agree with the above posts that discussed different aspects and the importance of clinical research on human trials. Undeniably, there is always a possibility…   Read more»

]]> 37f381cb98178d27298e2507d2e8f65c https://medicaldevicecourses.com/activity/p/23777/ Mon, 18 Oct 2021 13:45:37 -0400 I would have chosen marketing over sales as a Biomedical Engineer. The marketing manager has to deal with all the departments present in the company like R&D, Operations, Quality Assurance, Management, Sales, etc. Since engineering people do have sound technical…   Read more»

]]> bffe32485c16b99d550c04a8d53efbf9 https://medicaldevicecourses.com/activity/p/23776/ Mon, 18 Oct 2021 13:45:36 -0400 3e81005cc2a695376f3adaf32fc0b83d https://medicaldevicecourses.com/activity/p/23775/ Mon, 18 Oct 2021 13:45:35 -0400 Dental tools include the instruments that dental professionals use to provide dental treatment. Sickle Probe, Scaler, Saliva Ejector or Suction Device, Dental Syringe, Molds are some of the examples of dental tools.  These tools are generally used in dental clinics…   Read more»

]]> f75839493d21998a165e55c2eb8dc174 https://medicaldevicecourses.com/activity/p/23527/ Thu, 30 Sep 2021 13:03:59 -0400 I personally like to work in an environment where people with different backgrounds, socioeconomic and cultures work together to accomplish a goal. Especially, fields like regulatory having cultural diversity will help a lot. Knowing most of the norms and cultures…   Read more»

]]> 611d6b6a22e0ec316ae393859b6da4e6 https://medicaldevicecourses.com/activity/p/23526/ Thu, 30 Sep 2021 13:03:59 -0400 Recently, Armstrong Medical Limited recalled their product named AMSORB PLUS which absorbs carbon dioxide from cellular respiration during anesthesia. This substance is provided in a prefilled cylindrical container that is attached to the ventilator/anesthesia machine.  The reason for recalling this…   Read more»

]]> 27f9c00c984210d6e9735a90caaab429 https://medicaldevicecourses.com/activity/p/23525/ Thu, 30 Sep 2021 13:03:58 -0400 Since 1976, manufacturers have got a chance to get expedited approval from FDA if they can prove their device is similar to a device produced in or before 1976. Eventually, that means we’re still comparing with technology that’s decades old….   Read more»

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