marvint3

Forum Replies Created

RE: Failure's of Pre-Clinical / Clinical Research

There are a number of subjects and variables at play when potential research fails in the post clinical trial. For example the animals you receive may have some sort of toxin that makes them sick befo...

In forum Pre-clinical Device Development

6 years ago
RE: Ethics of Animal Testing

As far as ethical standards of using animals all labs are supposed to follow strict guidelines to ensure the animals are respected. But at the end of the day subjecting living things capable of feelin...

In forum Pre-clinical Device Development

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

Personally, I believe researching for the current generation allows the future population to have a basis of technology and research to base their study off of. Me personally I can't try to combat a p...

In forum Pre-clinical Device Development

6 years ago
RE: Forming a Project Team

In life there is a want to work with the perfect type of people, those who are not only knowledgeable, but sociable and likeable by the staff. You can get lucky every now and then and get the perfect ...

In forum Organizational Development in Device Companies

6 years ago
RE: Restrictions for physician's gifts

Roberto, I believe the restrictions are absolutely necessary to prevent tampering from the companies. These gifts can already be seen as a bribery by the company in order to create bias. This rule sho...

In forum Consultants and Legal Basics

6 years ago
RE: Risk Identification

Risk are generally analyzed by a given history and test ran on vaccines before giving them to patients. We generally also ask for patient history to understand if there are any type of adverse reactio...

In forum Risk Analysis for Medical Devices

6 years ago
RE: Risk analysis in real company

The risk assessment process for medical devices can go all the way back to design stages of medical device development. In this phase a lot of medical research is done in order to think of all possibl...

In forum Risk Analysis for Medical Devices

6 years ago
RE: Discussion Topic: Risk Management, Risk Analysis

The major ISO regulation for medical device risk management would be the ISO 14971:2007 and it comes with a plethora of requirements. This regulations assist the company in establishing, documenting, ...

In forum Risk Analysis for Medical Devices

6 years ago
RE: Consequences Of Insufficient Design Controls

Hello Lamiaa, Many times insufficient quality checks can lead to dire consequence not only for the consumer but also for the manufacture. Generally speaking devices not properly monitored can lead to ...

In forum Introduction to Design Controls

6 years ago
RE: What are Design Controls?

Design controls are implemented by the FDA in order to build quality, safety and ethical medical devices. Voluntary recalls in the 80's may have presented if the adequate design system were in place t...

In forum Introduction to Design Controls

6 years ago
RE: Important Part of DDP

I believe that the team member list/responsibilities are some of the most important aspects of the DDP. Because individual responsibilties are the general make up of the whole project, they are the "w...

In forum Introduction to Design Controls

6 years ago
RE: Clinical Trial Roles

I would prefer to be the medical writer, they have a very important role after the research is done. Not only are there many sources of employees, like pharmaceutical companies, hospitals or governmen...

In forum Clinical Research Basics

6 years ago
RE: Placebo-controlled trials: Are they ethical? Are they necessary ?

Personally I believe it is unethical to use placebo controlled trials, but they are a necessary evil. If we go back and look at the the Tuskegee Syphilis study the subjects were told they were being t...

In forum Clinical Research Basics

6 years ago
RE: Manipulation or no?

If you're thinking from a philosophical point of view then any form of marketing dealing with medical applications would be emotional manipulation. But only if they are dealing directly with the custo...

In forum Marketing and Sales

6 years ago
RE: Corporate Veil

A less common form of fraudulence would be a companies members create "shell" corporations by depositing and transferring debt to the shell company. When the companies have had to much debt to the ext...

In forum Business 101

6 years ago
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