elm33

Forum Replies Created

RE: Benefits for Patients in Clinical Research

Coming back to read these responses, I agree with all of you. There are certain situations where it is ethical, but there are some that it is a flat out no. I personally think that the higher the risk...

In forum Clinical Research Basics

4 months ago
RE: Feeling Safer?

I have come back to read all of your responses and totally agree with your points. I, too, feel a lot safer knowing that these steps are taken in order to really validate and verify product on the mar...

In forum Introduction to Design Controls

4 months ago
RE: Company Insurance

Coming back to this forum and reading all of your responses, I agree with all of you. There should be a plan in place just to make sure that the company continues to run smoothly. Nothing would be abl...

In forum Consultants and Legal Basics

4 months ago
Company Insurance

Imagine you are the owner of a company, if something were to happen to you, would you think it would be beneficial to have a mapped out plan of legal proceedings and how to handle deals while you coul...

In forum Consultants and Legal Basics

5 months ago
RE: Confidentiality and Transparency in Consulting Agreements

I feel as though a balance of an NDA and transparency is a big skill when being a part of a company, especially when making deals. I believe NDA's are good as long as no party is hurt or damaged in th...

In forum Consultants and Legal Basics

5 months ago
RE: Verbal Contracts

Verbal contracts are very hard to follow, especially when things go south. Although many people do verbal contracts, I feel as though there should be written evidence to an extent. Some examples of th...

In forum Consultants and Legal Basics

5 months ago
RE: Traits of upper management versus middle management

After seeing many sides of management I believe that the higher the level in management, the more versed the person is in the company and in the position. I think that upper management sort of leads t...

In forum Organizational Development in Device Companies

5 months ago
RE: Value-based healthcare: "Dos and Don'ts"

I agree with the other poster above, healthcare workers are always working for the most cost effective but also most effective treatments for their patients. In the end, money is a big player in to wh...

In forum Organizational Development in Device Companies

5 months ago
RE: AI & IoT in medical device industries.

I believe that companies need to thoroughly adapt to new technologies as that is what is currently relevant in the world. I will talk more with AI as it seems to be an ever growing topic today. It is ...

In forum Organizational Development in Device Companies

5 months ago
RE: Hazard, Hazardous, Harm

An example I can think of is similar to yours, with a biohazard. I know in New Jersey, when an animal has bit a person and is to be put down in the following 10 days, it is routine (as horrible as thi...

In forum Risk Analysis for Medical Devices

5 months ago
RE: Risk Acceptance

As I mentioned in another post, sometimes what we do not know... we may not know as there are endless possibilities in the world. Unfortunately with many things in the past, with new research, they ar...

In forum Risk Analysis for Medical Devices

5 months ago
RE: Residual risk during device development

I find that there is residual risk in any medical device just like how there is always risk when you have a surgery or a procedure. There are infinite possibilities when thinking about the potential r...

In forum Risk Analysis for Medical Devices

5 months ago
Feeling Safer?

The past week we have learned about Validation and Verification. After learning about these two topics, do you feel safer knowing that these can be applied to medical devices that we use/may use in th...

In forum Introduction to Design Controls

5 months ago
RE: Design "Overvalidation"?

In my opinion I do believe that over-validation can happen easily as companies want to make sure their product is proper. I do though feel like teams want to secure the goal with as little work as pos...

In forum Introduction to Design Controls

5 months ago
RE: Minutes for meetings

Hello! In my opinion, meeting minutes do matter as long as all topics and information was laid out on the table. Sometimes I find that when a meeting minutes time is established, people tend to worry...

In forum Introduction to Design Controls

5 months ago
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