https://medicaldevicecourses.com/members/rv395/activity/ Activity feed for rv395. Sat, 16 May 2026 08:28:56 -0400 https://buddypress.org/?v= en-US 30 hourly 2 b76198ec6f60e15e5e5942ff23711416 https://medicaldevicecourses.com/activity/p/20995/ Sun, 22 Nov 2020 21:12:33 -0500 NDA’s are legally binding documents so we should read it carefully before signing. We need to be aware of the terms in the document and clarify any vague statements before signing. NDAs should provide clear and specific terms to detail…   Read more»

]]> 0d4f549e9e81d552fc0bc92f8d88d322 https://medicaldevicecourses.com/activity/p/20994/ Sun, 22 Nov 2020 20:51:41 -0500 Alternative Dispute Resolution (ADR) can be effective because they are speedy than going to courtroom and also reduces the cost. Moreover the result can be kept confidential in ADR whereas most court trials and are open to the public.  Another…   Read more»

]]> 3d64a3553d0f06474776ebe38478f9ae https://medicaldevicecourses.com/activity/p/20993/ Sun, 22 Nov 2020 20:15:09 -0500 Consultants usually have experience of working in the domain of the developed Medical device and they can provide a viewpoint which the company realises to see. Consulting an physician expert in the field will surely increase the chances of obtaining…   Read more»

]]> 469f43c4a5214760eddf6e191355b087 https://medicaldevicecourses.com/activity/p/20986/ Sun, 22 Nov 2020 17:22:28 -0500 My preference would be to work in a matrix structure because it can increase efficiency to meet the demands of the project by collaboration with various teams. This structure can also help to increase skills of employees.

]]> c946fe62f7e411cf77ccdfc5f1f30231 https://medicaldevicecourses.com/activity/p/20985/ Sun, 22 Nov 2020 16:38:29 -0500 When I worked as a Research assistant, there was matrix structure where I reported to immediate supervisor and project manager. As long as there was proper communication between the team member and supervisor there wasn’t any issue with the structure….   Read more»

]]> 7205a5a599682f863f9dfd3d9e2d6faf https://medicaldevicecourses.com/activity/p/20984/ Sun, 22 Nov 2020 16:26:57 -0500 The important trait of upper management in any industry is leadership quality. They foresee the future of company and set the vision for everyone to work towards it.Their leadership role can extend over the entire organization and they are responsible for…   Read more»

]]> 5d8eeba65cd9d1d33e5bc4575a2deae8 https://medicaldevicecourses.com/activity/p/20906/ Sun, 15 Nov 2020 17:19:04 -0500 The risk register is an important document in the product life cycle and it has to be updated continuously with the following information –  Prioritised list of quantified risks which were resolved Trends in quantitative risk analysis which had significant…   Read more»

]]> 4179a8718fde5db32c50476e8e9446aa https://medicaldevicecourses.com/activity/p/20905/ Sun, 15 Nov 2020 17:09:32 -0500 Like everyone suggested in the previous posts, Information Gathering techniques are proven for Risk identification. These techniques involve sessions like Checklist analysis where risks in previous devices have been ticked out. Also Assumption analysis help identify any new risks which…   Read more»

]]> 38df1f8dc919489b788a405bf8647661 https://medicaldevicecourses.com/activity/p/20904/ Sun, 15 Nov 2020 15:55:32 -0500 Some of the basic tools used are  1. SWIFT Analysis – Standing for “Structured What-If Technique” where the project members apply a systematic, team-based approach in proposal environment, where the team investigates how changes from an approved design, or plan,…   Read more»

]]> fc4766e62c36e5a80e62dfdc40166dfc https://medicaldevicecourses.com/activity/p/20833/ Sun, 08 Nov 2020 04:24:00 -0500 In combination products design controls, the clinical trials takes place as three constituents – for drug constituent part, the device constituent part and the combination product as whole. The implication from each part help change the impact on the combination…   Read more»

]]> a85c0462038e850a91a6d4c857688504 https://medicaldevicecourses.com/activity/p/20831/ Sun, 08 Nov 2020 00:21:37 -0500 Drugs trials are conducted in three phases, starting with an introduction on a small number of healthy subjects, and then in large populations and then in population with the disease or condition indicated for treatment. And in devices, trials are…   Read more»

]]> 8252f6e520b65142cd191fb250d11900 https://medicaldevicecourses.com/activity/p/20830/ Sat, 07 Nov 2020 23:40:06 -0500 Document control is very essential in device changes. It helps maintain a quality system or a device. An example of device change that is controlled is device specification which will be be usually updated with the arrival of better specification…   Read more»

]]> ac5d0a43a8192c9ba082a17c2d23705d https://medicaldevicecourses.com/activity/p/20733/ Mon, 26 Oct 2020 22:39:44 -0400 Randomization is used to reduce the bias in assigning patients to study treatment groups and it provides unbiased assessment of the effects of different medical treatments. Both randomization and blinding are important tools in determining the effectiveness of a clinical…   Read more»

]]> 74ed957160dbb5b8faecdf164ac9dd24 https://medicaldevicecourses.com/activity/p/20730/ Mon, 26 Oct 2020 17:35:32 -0400 As of January 2020, it has been reported that one patient with amyotrophic lateral sclerosis, or ALS, has received an investigational drug from BrainStorm Cell Therapeutics and seven patients have received an immunotherapy vaccine under evaluation for glioblastoma under the…   Read more»

]]> 9329e467c101457e8be941d42994b51c https://medicaldevicecourses.com/activity/p/20729/ Mon, 26 Oct 2020 16:19:58 -0400 Although I have never experienced Adverse effect during clinical trials, I agree to the possibly of incorporating wearable technologies into the protocol for effective physiological monitoring. AE’s are unanticipated and the wearable sensors provide supporting documentation which can be used…   Read more»

]]> 48c197c6d433818127e0b31d788968ec https://medicaldevicecourses.com/activity/p/20647/ Sun, 18 Oct 2020 15:09:55 -0400 According to me, In order to create an organisation that is both dynamic and responsive to the market while still generating revenue, the relationship between sales and product management needs to go hand in hand. However sales is armed with…   Read more»

]]> 4763f1043e7c24450eccabb027bb8a72 https://medicaldevicecourses.com/activity/p/20646/ Sun, 18 Oct 2020 14:28:35 -0400 During this Covid-19 pandemic crisis time, Companies around the world have come up with innovative advertisements to sell their products. Trying to create ads that seek to capture the emotions and feelings generated by large crisis can be very tricky….   Read more»

]]> 3f6251dac88fd3836441f6b1536e410a https://medicaldevicecourses.com/activity/p/20632/ Sat, 17 Oct 2020 00:34:51 -0400 As discussed in previous posts, Product management’s responsibility is to prototype and develop a product that fulfils customers need and eventually gets purchased.  It is based on the market requirements, and a good team will consistently adapt to recent feedback…   Read more»

]]> 991bff1c7fd963267ef6d256937be40d https://medicaldevicecourses.com/activity/p/20570/ Thu, 08 Oct 2020 23:23:30 -0400 I very well agree with the previously mentioned posts that successful partnership can be formed based on the size of the business and number of people who wish to be the partners. Once the agreement addresses how decision-making power will…   Read more»

]]> 7f8c6dc5172cf9faf5bdf3e2564925dc https://medicaldevicecourses.com/activity/p/20569/ Thu, 08 Oct 2020 21:12:10 -0400 I agree with the previous posts. There are many benefits in DBA compared to a LLC. The benefits are listed in the below link are – Compliance, Business banking and Flexiblity.  https://exitpromise.com/what-is-a-dba/ Another advantage is the low-cost and easy to…   Read more»

]]> c3b796bb6f84657f54b63d1368a885eb https://medicaldevicecourses.com/activity/p/20568/ Thu, 08 Oct 2020 20:09:45 -0400 If I were to start my own business in a Medical Device setting, I would choose a partnership route. By this way I have complete control of the process and also by joint venturing with another partner who is well…   Read more»

]]> b7eb9bc7f36c3077d7f5b839934552f3 https://medicaldevicecourses.com/activity/p/20504/ Fri, 02 Oct 2020 03:31:18 -0400 Being an International student myself, I have had the opportunity of working with other international students in projects developing CAD models of Medical devices. As said in previous lectures Communication is the key and effective communication while working with people…   Read more»

]]> f40b702388b1b64db592c5cbd983d780 https://medicaldevicecourses.com/activity/p/20496/ Thu, 01 Oct 2020 03:15:35 -0400 I agree to the previous posts that Jurisdiction of combination drugs is determined by their primary mode of action- “the single mode of action of a combination product that provides the most important therapeutic action of the combination product” but…   Read more»

]]> 06823679a47a54e4ae5ac2fd932fbd2d https://medicaldevicecourses.com/activity/p/20495/ Thu, 01 Oct 2020 03:01:09 -0400 One of the FDA announcement during the Covid-19 situation is the recall of hand sanitisers which contain methanol in them. Methanol is a dangerous substance and during these tough times where mask and hand sanitisers are indispensable, it is hard…   Read more»

]]> 8f220e4da20e8cfd3bd8a4a37de51479 https://medicaldevicecourses.com/activity/p/20494/ Thu, 01 Oct 2020 02:30:18 -0400 When I worked as a QA Intern in a nutraceutical company, we tested a small amount of all the raw material samples for their strength and the presence of heavy metals, pesticides in them. The raw material were released for…   Read more»

]]> cfa3de426632e117fc865c781046edcf https://medicaldevicecourses.com/activity/p/20493/ Thu, 01 Oct 2020 00:25:02 -0400 To improve the overall Standard of the company it is very important all the departments ensure data transparency to make sure Quality department takes steps to document it and makes sure it does not happen.  This can be achieved only…   Read more»

]]> 0b1f2def043387cf6ab6bf006b92d239 https://medicaldevicecourses.com/activity/p/20492/ Wed, 30 Sep 2020 23:59:37 -0400 In my opinion, Quality assurance is like a continuous feedback of the on-going process. It ‘”assures” the quality is maintained from start to finish and Quality control is a subset of Quality Assurance which helps keep tabs on the process…   Read more»

]]> 57e191b5bfa12e6d8c02b3dbac6e0275 https://medicaldevicecourses.com/activity/p/20348/ Sat, 19 Sep 2020 00:51:02 -0400 The emergence of Covid-19 certainly affected Pre-Clinical/Clinical research in many ways. Lab protocols were modified according to the new regulations. It led to the failure of research involving human contact. Such studies were temporarily paused until the situation became better….   Read more»

]]> a0cbb13eba440538d99f5ffb231091be https://medicaldevicecourses.com/activity/p/20347/ Sat, 19 Sep 2020 00:16:23 -0400 Animal testing in pre-clinical research are critically important to study their combinational responses in a biologic system controlled by the brain. The same study when taking place as a computer simulation or as in vitro in a petridish does not…   Read more»

]]> 8141569ba52d7c3762920bd469dbe04c https://medicaldevicecourses.com/activity/p/20346/ Fri, 18 Sep 2020 23:55:56 -0400 According to me, Industrial research sells out easily because the scope and output is more or less predictable. Most of the times there is already a similar model or proposal made by the industry. When I worked in an industrial…   Read more»

]]> daf29b2026877c25dd73ac7a6030db11 https://medicaldevicecourses.com/activity/p/20341/ Thu, 17 Sep 2020 16:08:31 -0400 When I worked as a Grad assistant in university I worked with a really good Manager who had strong leadership skills and effective communication skills. Being in Academia, he made sure every team member’s time was effectively used to maximise…   Read more»

]]> faca50b6dc34bfe91c7d25f063461ab1 https://medicaldevicecourses.com/activity/p/20340/ Thu, 17 Sep 2020 15:34:14 -0400 Lean process management is now being used extensively in the healthcare industry to improve efficiency and reduce costs. According to PMI, Lean Management introduced five core concepts: 1) Specify value in the eyes of the customer 2) Identify the value…   Read more»

]]> 01d283a098fc18abe5f734c119b605e0 https://medicaldevicecourses.com/activity/p/20338/ Thu, 17 Sep 2020 01:24:41 -0400 I feel one of the obstacles when embarking on a new project is making sure everyone has proper documents and SOP’s which has to be followed. When I was working as a QA Intern, there was a process improvement project…   Read more»

]]> eeaf717db1f0a0391213b81bfec8e2d5 https://medicaldevicecourses.com/activity/p/20229/ Mon, 07 Sep 2020 19:30:41 -0400 With varying health issues arising everyday, there is a need for personalised healthcare for affected individual. To provide a viable solution Bio-Engineering deals at the cell-tissue level of organs to study their molecular and structural composition. Some of the courses…   Read more»

]]> b45fe0f02136f9e17d8ae5941f742e7c https://medicaldevicecourses.com/activity/p/20228/ Mon, 07 Sep 2020 17:48:12 -0400 I feel that after completing a Bachelors and being a Master’s student in Biomedical Engineering, I know a “little bit of everything”. I don’t feel lost in a topic discussed by my Professors or Colleagues from Chemical, Mechanical, Electrical or…   Read more»

]]> c207bc8fc38990eaa244f5c3877b528b https://medicaldevicecourses.com/activity/p/20204/ Sat, 05 Sep 2020 02:24:46 -0400 afabbe1c954e87e482606920a67f353d https://medicaldevicecourses.com/activity/p/20203/ Sat, 05 Sep 2020 02:24:42 -0400 7c60b85f41921b72e711f8486b78931d https://medicaldevicecourses.com/activity/p/20202/ Sat, 05 Sep 2020 02:24:06 -0400 I feel the coursework should be emphasised towards at least 60:40 if not 50:50 where the former being informational and latter being practical courses. At times, when the informational courses start getting too theoretical, we need to look at concepts…   Read more»

]]> 5796bfd2ff08096163c03dcdcb9ab2dd https://medicaldevicecourses.com/activity/p/20201/ Sat, 05 Sep 2020 01:36:59 -0400