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Forum Replies Created

RE: FDA Approval During Public Health Emergencies

The FDA's responsibility is to guarantee that medical products adhere to exacting safety and efficacy standards. This process, known as "full approval," can take years. The FDA continues to maintain i...

In forum Regulatory Basics for Medical Devices

2 years ago
RE: What are some ways Document Control can improve?

Document control is a crucial component of an efficient internal control system, which is necessary for compliance with regulations like ISO 9001, ISO 13485, IATF 16949, etc. When done manually, docum...

In forum Quality Control and Quality Assurance

2 years ago
RE: Cutting Corners in Research

In general with anything in life cutting corners and taking shortcuts can lead to serious consequences. The research process relies on trust, and trust is essential for maintaining research integrity....

In forum Pre-clinical Device Development

2 years ago
RE: Discussion Topic: Biomaterial Selection

The selection of a biomaterial is crucial for medical device project management. Some factors to consider when selecting a biomaterial are cost, biocompatibility, and accessibility just to name a few....

In forum Pre-clinical Device Development

2 years ago
RE: Research for the Fututre or Now?

I couldn't agree with you more. While doing research for the future has its benefits, why not do research for something that can benefit something in today's time that could also double in research us...

In forum Pre-clinical Device Development

2 years ago
RE: Automated and Programmable Medical Devices ?

With the advancement of technology every second of the day, it is very possible that automated systems could take over some positions that currently require actual employees but it could also increase...

In forum Introduction to Medical Device Development

2 years ago
RE: Milestones Missed: Failure or Success?

Hello, I think that this is such a great discussion question, especially considering that the older we get we tend to always think that not achieving a task whether small or large is an automatic fail...

In forum Intro to Project Management

2 years ago
RE: People in a Project

Hello Leah, This was a fantastic discussion post, and I appreciated how you connected the subject to your experience as a former athlete. Teamwork is essential in every industry, to answer your questi...

In forum Intro to Project Management

2 years ago
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