Andy 86

Forum Replies Created

RE: Audit Culture

Audits are something I do have experience with when I was managing a lot of communication equipment. I understand how PAINFUL they can really be, especially if poorly mismanaged from previous personne...

In forum Quality Control and Quality Assurance

1 month ago
RE: Quality Control & Quality Assurance Communication

In the strict sense for the last sentence and technically, I don't think I've ever been in the position to have a negative experience with QC and QA. I agree that the PDCA cycle highlights the depende...

In forum Quality Control and Quality Assurance

1 month ago
RE: Unified Quality System?

In terms of the hierarchy of quality, in my own way, I do think that a unified quality system sounds ideal. I naturally gravitate towards that given the experience I have with similar leadership so in...

In forum Quality Control and Quality Assurance

1 month ago
RE: Are Regulations Helping Innovation or Slowing It Down?

To me, regulation can seem like a double edge sword, but I'd like to say outright that I think safety is paramount. With this in mind, the FDA's intense and rigorous observations should build trust fo...

In forum Regulatory Basics for Medical Devices

2 months ago
RE: Does the FDA guarantee safety?

While one would hope that the FDA does guarantee safety, I don't believe that to be the case. I think instead, the FDA, with as much scientific evidence and proof that is both gathered and tested, wei...

In forum Regulatory Basics for Medical Devices

2 months ago
RE: FDA on Recalled Items

As there are some other discussions that have similar topics involving safety of an approved medical device or drug, again it's important to see that safety is not 100% guaranteed, but the benefits do...

In forum Regulatory Basics for Medical Devices

2 months ago
RE: Key factors to consider while selecting appropriate animal models for pre-clinical research to develop therapies for neurological disorders.

Trying to find the right balance between biological relevance and practicality is crucial for selecting a viable animal model (especially in a pre clinical research). When selecting a species, they sh...

In forum Pre-clinical Device Development

2 months ago
RE: Why Is Pre-clinical Research So Important Before Testing on Humans?

I think companies should focus on developing lab models and simulations on most projects. I can be a sucker for animals, but I do understand that it is necessary sometimes. Developing lab models can l...

In forum Pre-clinical Device Development

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

If we are talking on an individual basis on what I would rather do? I would rather work on an industry level that affects the current generation. For me personally, I think my skills and learning capa...

In forum Pre-clinical Device Development

2 months ago
RE: Quality and Risk Management in the Project Life Cycle

Looking at this question, my thoughts and opinions reflect similarly to the previous reply I made to in relation to communication between the group members and leadership. In this case, while in my pr...

In forum Intro to Project Management

2 months ago
RE: Managing Team Opinions While Sticking to Decisions

I believe having a manager or lead that actively listens to the members of the group promotes a healthy discussion towards the betterment of the project at hand. Ultimately, it does fall onto the lead...

In forum Intro to Project Management

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

To answer the question of whether missing a milestone is considered a failure or success: it is considered a failure. Simply, it is a failure because the deadline was just not met; it does not matter ...

In forum Intro to Project Management

2 months ago
RE: Thoughts on BME degree, "a little of everything"

I do like the fact that this pursuit does make you knowledgeable in wide variety of areas (as I echo what everyone else says, being a jack of all trades). Being able to slot yourself into multiple pos...

In forum Introduction to Medical Device Development

2 months ago
RE: Experience vs Education

Similarly to what Natalie mentioned, I do not have biomedical industry/work experience in the field and I have to talk from what I've heard from others and what I would expect. To express my thought o...

In forum Introduction to Medical Device Development

2 months ago
RE: Academia or Industry Preference?

It's really fascinating reading about everyone's experiences, expectations and reality when considering either academia or industry work. Personally, and I feel this is resonating with everyone else, ...

In forum Introduction to Medical Device Development

2 months ago
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