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Forum Replies Created

Auditing Bodies

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 certi...

In forum Regulatory Basics for Medical Devices

5 years ago
RE: Discussion Topic: Biomaterial Selection

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 sc...

In forum Pre-clinical Device Development

5 years ago
RE: Talking about animal research

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 ...

In forum Pre-clinical Device Development

5 years ago
RE: Project Objectives

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...

In forum Intro to Project Management

5 years ago
RE: Project Management Softwares

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 ...

In forum Intro to Project Management

5 years ago
RE: FDA Consultants in medical devices projects

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...

In forum Intro to Project Management

5 years ago
Ethics and Regulation of Medical Device Development and Manufacturing in Times of Crisis

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 ...

In forum Introduction to Medical Device Development

5 years ago
RE: Discussion Topic: Covid19 and medical devices

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 h...

In forum Introduction to Medical Device Development

5 years ago
RE: The Advantages and Disadvantages of Being Overqualified

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 sala...

In forum Introduction to Medical Device Development

5 years ago
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