Medical Device Courses | mduru | Activity

mduru replied to the topic "Non Compete Agreement" -

Sat, 28 Nov 2020 11:23:39 -0500

I’ve had to sign a non-compete agreement 3 times so far. First was when I worked for a consulting firm – I was not allowed to work directly for their clients or recommend their employees for hire to my new… Read more»

mduru replied to the topic "Severance and Release Agreement" -

Sat, 28 Nov 2020 11:18:35 -0500

Fortunately, I have not yet been laid off and gone through this. However, I have gotten a release letter from when I wanted to leave my consulting firm. They tried to take advantage of the fact that if I quit… Read more»

mduru replied to the topic "Consultants in the Medical Device Industry" -

Sat, 28 Nov 2020 10:28:11 -0500

Consultants are generally hired when a company does not have the specific resources for a task/project or the company does not have enough resources to complete task/project on time. In my previous job we hired the an engineer who had… Read more»

mduru posted a new topic "Different Organizations for Different Industries" -

Sun, 15 Nov 2020 22:22:21 -0500

This week we learned some of the advantages and disadvantages of 3 organization types: Functional, Project-Based, and Matrix. Are there any industries (or even specific companies) you can think of that might benefit most from one of the three? Why… Read more»

mduru replied to the topic "Discussion Topic: Your organizational type" -

Sun, 15 Nov 2020 22:12:43 -0500

Every company I’ve worked for has so far been a matrix organization. While I have not had experience functional or project-based organizations, I feel confident in saying that I would prefer matrix organizations. Even in matrix organizations I’ve noticed politics… Read more»

mduru replied to the topic "Traits of upper management versus middle management" -

Sun, 15 Nov 2020 22:03:36 -0500

Posted by: @sts27 In all honesty, I think that the traits of upper and middle management are quite similar (depending on how you look at them). Both are required to be able to communicate effectively, articulate plans and goals, monitor… Read more»

mduru replied to the topic "Risk Management Tools" -

Sun, 15 Nov 2020 21:56:47 -0500

Posted by: @traceymraw Based on the risk management tools mentioned in the lecture (Failure Mode Effects Analysis (FMEA), Brainstorming, and Fish Bone Diagram), which have you used on projects in the past? Which do you find the most beneficial or… Read more»

mduru replied to the topic "Discussion Topic: Risk Management, Risk Analysis" -

Sun, 15 Nov 2020 21:52:44 -0500

ISO 14971 is the ISO regulation governing Risk Management and its major requirements for medical devices are: Identify risks Estimate the potential occurrence of risk and evaluate extent of consequences Put in safeguards to control risks Regularly review and monitor… Read more»

mduru replied to the topic "Auditor's view of DHF / DHR" -

Mon, 09 Nov 2020 03:57:25 -0500

I’ve participated in a couple of audits. US FDA, Korean FDA, Internal, and MDSAP. My participation was always limited to specifically my documents so I was questioned on some things but was able to adequately clarify everything. Some of the… Read more»

mduru replied to the topic "Validation Types" -

Mon, 09 Nov 2020 03:48:31 -0500

I’ve done and am actually in the middle of a shelf life validation for raw materials and final device. We’ve included in it packaging, transportation, and storage studies in accelerated and real-time aging. In the past, I’ve done software validations… Read more»

mduru replied to the topic "Medical Device Clinical Trials vs Drug Trials" -

Mon, 09 Nov 2020 03:41:33 -0500

They are related in a sense that both are used medically but they both have different levels of risk. Medical devices, whether it be implants or blood typing machines, aren’t chemical compounds made to react a certain way in the… Read more»

mduru replied to the topic "A day in the life working in QA/QC" -

Sun, 18 Oct 2020 01:55:58 -0400

From what I have observed during my working experience in Medical Device companies as Production Engineer, Quality seems to operate under two main strands: Quality (Ops) and Quality (Compliance). As Production Engineer- I have gained experience with working both sides…. Read more»

mduru posted a new topic "Perception of QA/QC" -

Sun, 18 Oct 2020 01:52:25 -0400

As with many lines of work, people tend to have a certain perception of what that field or role is like. What were some of your perceptions of QA/QC and have they changed after this lecture? Have you had a… Read more»

mduru replied to the topic "Drugs banned in US but not in other countries" -

Fri, 25 Sep 2020 21:13:41 -0400

@bjv9 Yeah, absolutely, some countries have have regulations that are more strict than the US and for that reason some drugs or devices banned in other countries are actually deemed safe in the US. For example: Sudafed is available in… Read more»

mduru replied to the topic "Regulatory Projects Worked On" -

Fri, 25 Sep 2020 20:59:42 -0400

My previous employer sells blood typing kits to many countries around the world and we are regulated by several bodies around the world. While most of their focus overlaps other things like labeling requirements have small differences which could mean… Read more»

mduru posted a new topic "Auditing Bodies" -

Fri, 25 Sep 2020 20:42:51 -0400

My previous employer sells blood typing kits to many countries around the world and we were audited by several bodies. Before starting MDSAP, we were audited separately by the FDA, LRQA (for ISO certification), Brazil’s FDA, CFIA, Korean FDA, and… Read more»

mduru replied to the topic "Discussion Topic: Biomaterial Selection" -

Fri, 25 Sep 2020 19:08:50 -0400

Posted by: @orleron Up until now we have talked about two big topics: project management and pre-clinical research. There are some other discussions in this forum about biomaterial selection for scientific and safety purposes, but I want now to talk… Read more»

mduru replied to the topic "Talking about animal research" -

Fri, 25 Sep 2020 18:55:43 -0400

I think it would be appropriate to say this topic is like a double edge sword. Just as with any controversy or disagreement, I think dialogue is the best way to go about it. Both side need to discuss the… Read more»

mduru replied to the topic "Project Objectives" -

Sun, 13 Sep 2020 20:49:42 -0400

The most important things is will. What is achievable, understandable, and affordable? While these are absolute in their importance and relevance, they’re all ultimately subjective. Your idea could be achievable, understandable, affordable, and solving a very important problem but the… Read more»

mduru replied to the topic "Project Management Softwares" -

Sun, 13 Sep 2020 20:29:42 -0400

I think hands down MP (Microsoft Project) is the most comprehensive and most popular PM (Project Management) software out there. It’s a part of the Office Suite of software from Microsoft that easily integrates with other Office software. For example,… Read more»

mduru replied to the topic "FDA Consultants in medical devices projects" -

Sun, 13 Sep 2020 20:12:37 -0400

I agree with you Jafar, I think it’s a good idea to have RA (Regulatory Affairs) in the first meeting as well. Having input from RA could help prevent issues in the future of the project. I personally know of… Read more»

mduru posted a new topic "Ethics and Regulation of Medical Device Development and Manufacturing in Times of Crisis" -

Tue, 08 Sep 2020 00:54:52 -0400

During the COVID19 pandemic we’ve seen significant shift of resources in many industries. The medical device industry was one of the industries that felt this shift the strongest. Some approvals were fast tracked by regulators while some others put on… Read more»

mduru replied to the topic "Discussion Topic: Covid19 and medical devices" -

Mon, 07 Sep 2020 23:23:05 -0400

COVID19 has in some ways helped and continue to help use in our methods and technology. As mentions in previous posts, companies and people who originally had nothing to do with the medical industry have now gotten involved in the… Read more»

mduru replied to the topic "The Advantages and Disadvantages of Being Overqualified" -

Mon, 07 Sep 2020 23:09:08 -0400

I think it really depends on what you want and company culture as well as your management. Here are a few advantages I see in being over qualified: Advantage over others who are seeking the same salary and position. Opportunities… Read more»

mduru became a registered member

Fri, 04 Sep 2020 22:11:38 -0400