hc255

Forum Replies Created

RE: R&D vs Quality

Quality is put in place to police R&D and other departments to ensure that effectiveness and suitability of processes are maintained across all levels. With that being said, both departments are c...

In forum Quality Control and Quality Assurance

8 years ago
RE: Issues with the Quality Department

I currently work as a Quality Engineer and still there exists some issues within the quality department. First and foremost, document control. Every procedural change or creation of procedure needs to...

In forum Quality Control and Quality Assurance

8 years ago
RE: FDA on Recalled Items

In 2015, Medline Industries, Inc. had a voluntary recall of one lot of acetaminophen tablets. The issue here was that the bottles were incorrectly labeled as showing 325mg instead of 500mg. The risk o...

In forum Regulatory Basics for Medical Devices

8 years ago
RE: Combination Product

Immunostimulating hydrogels are a combination product. Hydrogels depending on the peptide structure are chemically synthesized through peptide synthesis. Designer hydrogels can have small growth facto...

In forum Regulatory Basics for Medical Devices

8 years ago
RE: Discussion Topic: Antibiotic-Releasing Hip Stem

An antibiotic-releasing hip stem would fall under various categories including: device combined with a drug. This is due to the nature of the product. The device portion stems from the provider or car...

In forum Regulatory Basics for Medical Devices

8 years ago
RE: Approaches to Research

Approaching research in an academic setting typically starts when a professor has an idea and decides to use their network to figure out possible solutions. Academic research is approached through int...

In forum Pre-clinical Device Development

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

I believe that research done now will benefit both the short term and long term. It depends on the type of research that is being conducted however. Industry related research can be used short term if...

In forum Pre-clinical Device Development

8 years ago
RE: Academia vs. Industry Research

Conducting research in academia is very different from industry but both have some striking similarities depending on the circumstances. For example, academia research is heavily supported by contract...

In forum Pre-clinical Device Development

8 years ago
RE: Discussion Topic: Project Management in a medical device setting

The challenges of doing project management are always present. These includes providing adequate information and communication avenues for the team members as well as the ability to track deadlines an...

In forum Intro to Project Management

8 years ago
RE: Obstacles while working on a project

Currently I am leading two CAPA investigations where we have to reconfigure data acquisition system which is set for revalidation in March. One of the biggest issues that we ran into was reaching adeq...

In forum Intro to Project Management

8 years ago
RE: Project Life Cycle

I believe the planning phase is the most crucial to the success of the project. If a plan is well thought out then the actions, executions, and other phases after the planning phase will go to plan. T...

In forum Intro to Project Management

8 years ago
RE: Advice for Biomedical Engineering Students

Advice I would give to Biomedical Engineering students would be to 1. network your butt off. This means going to conferences as a freshman in college, regardless of location. Going to meet ups sponsor...

In forum Introduction to Medical Device Development

8 years ago
RE: Discussion Topic: Academia vs. Industry

A career in academia allows oneself to have control of their own schedule - sometimes. It may depend on what experiments that person runs during the day which can extend the typical 9-5 to 9-9. Likewi...

In forum Introduction to Medical Device Development

8 years ago
RE: Discussion Topic: Practical vs. Informational courses

I believe it ultimately depends on the student's goals whether or not they would prefer practical vs academic courses. One could infer that courses that teach more practical applications related to in...

In forum Introduction to Medical Device Development

8 years ago
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