https://medicaldevicecourses.com/members/vkp3687/activity/ Activity feed for vkp3687. Sat, 16 May 2026 12:13:51 -0400 https://buddypress.org/?v= en-US 30 hourly 2 003bd752c80c5008b6b5b8ec8e462148 https://medicaldevicecourses.com/activity/p/28152/ Sun, 08 Oct 2023 19:45:11 -0400 The graduate program at the New Jersey Institute of Technology should contain a better ratio of academic to practical courses, I believe the ratio should be 50/50 to better prepare the students to the skills, knowledge and responsibilities needed for…   Read more»

]]> 11053b8fadbda7b97f9dba060b3ec47e https://medicaldevicecourses.com/activity/p/28108/ Mon, 02 Oct 2023 01:40:08 -0400 The regulation of medical drugs and devices involves competing goals of assuring safety and efficacy while providing rapid movement of innovative therapies through the investigative and regulatory processes as quickly as possible.  The United States and the European Union approach these challenges…   Read more»

]]> 4675e4b18ed1e6211d589e8ae521e385 https://medicaldevicecourses.com/activity/p/28105/ Mon, 02 Oct 2023 00:57:22 -0400 Every five years, top officials of the Food and Drug Administration go behind closed doors to negotiate the terms of its core budget — about $3 billion this year.  But the F.D.A. is not at the table with members of…   Read more»

]]> c369fb1d6bafc896e1ee1aaaf8179ac9 https://medicaldevicecourses.com/activity/p/28103/ Sun, 01 Oct 2023 23:56:47 -0400 The Food and Drug Administration (FDA) requires that medical device manufacturers establish and follow quality systems to help ensure products consistently meet applicable requirements and specifications.  The quality system regulations (QSR) for FDA regulated products are known as current good…   Read more»

]]> faed35d79802d18604488aa919b26dbb https://medicaldevicecourses.com/activity/p/28039/ Mon, 25 Sep 2023 03:16:41 -0400 When managing research in Industry, there is a “how to” guide for basic Research Scientists in Industry: Step 1: Your boss tells you to do a study. You may not know much about the subject, Do a literature search, Get…   Read more»

]]> 37c6dfcf7749efed4241d5d18d1b1a53 https://medicaldevicecourses.com/activity/p/28038/ Mon, 25 Sep 2023 02:40:04 -0400 The way research is being funded is also different between Academia and Industry.  In Academia, you apply for a grant – you write a very large document, you hope that you get the grant, the grant money comes in -…   Read more»

]]> 7973f26b84f198068b46f7d79116a3ca https://medicaldevicecourses.com/activity/p/28035/ Mon, 25 Sep 2023 02:20:12 -0400 When it comes to the valuing of research in making medical devices in academia, they do it for the love of it, “Neat-o!”, they believe they are helping people and they are also curious, they really do boldly go where…   Read more»

]]> fe161ed0018c4122918563a30aa1569f https://medicaldevicecourses.com/activity/p/27974/ Mon, 18 Sep 2023 00:57:41 -0400 Medical device manufacturers regulated by the FDA, EU, or any international regulatory agency must implement a quality management system for their medical device according to the applicable regulatory requirements, most often the FDA’s Quality System Regulations or ISO 13485.  But…   Read more»

]]> 599ec1cfd55d5a4998c9fdbd3c5375fa https://medicaldevicecourses.com/activity/p/27973/ Mon, 18 Sep 2023 00:35:47 -0400 Medical device product and project risk management can rarely exist without the other. This becomes apparent when you are responsible for the project meeting its objectives.  Along with this responsibility is the responsibility of compliance with all applicable regulatory and…   Read more»

]]> e2bda4f47ae9b180ea3fb09544814eda https://medicaldevicecourses.com/activity/p/27966/ Sun, 17 Sep 2023 05:17:49 -0400 Teamwork is essential in the Medical Device Development, Life Sciences and Biotech Industries, and it is the glue that ties everything together and generates answers.  Researchers in many fields, currently recognize that no single person can contribute all the necessary…   Read more»

]]> 5b170e46fff82be8aaeb40a75a2d96b4 https://medicaldevicecourses.com/activity/p/27915/ Mon, 11 Sep 2023 03:51:22 -0400 Due to the occurrence of a global virus pandemic during the past few years, changes in where and how we work have dramatically occurred.  Hybrid-style work arrangements I where employees work from home for a few days and in the…   Read more»

]]> 9c5160c7da43d25ab4f0be2491b56d6c https://medicaldevicecourses.com/activity/p/27914/ Mon, 11 Sep 2023 02:59:13 -0400 @jh597 The graduate program at the New Jersey Institute of Technology should contain a better ratio of academic to practical courses, I believe the ratio should be 50/50 to better prepare the students to the skills, knowledge and responsibilities needed…   Read more»

]]> 640d59926a973f37669ded9a410c9a81 https://medicaldevicecourses.com/activity/p/27912/ Mon, 11 Sep 2023 01:58:20 -0400 What is the best career choice after finishing your postgraduate degree – ‘industry’ or ‘academia?’”  It is really important to understand the differences between both career choices because the context of work changes when you pick one or the other…   Read more»

]]> 703d92fb826824641383e0d5c6fb7b7f https://medicaldevicecourses.com/activity/p/27866/ Sat, 09 Sep 2023 16:21:25 -0400 0