samscott

Forum Replies Created

RE: Written Agreement v/s Verbal Agreement

I would think that it would be difficult to prove a verbal contract. Since they are not written down, its existence has to be proven by memories of other parties or other acceptable evidence. The auth...

In forum Consultants and Legal Basics

4 years ago
RE: Forming a Project Team

Within a typical project team structure, projects are headed by the project manager of course, but the key characteristics of this type of team is that everyone reports to the project manager or anoth...

In forum Organizational Development in Device Companies

4 years ago
RE: how far is "As Far As Possible"

I believe it has to do with psychological concepts of anchor bias and a modern corporate culture that doesn’t allow employees to see the big picture of their work. Regardless of the reasons, it’s impo...

In forum Risk Analysis for Medical Devices

4 years ago
RE: Dealing with risk

The guidelines consider risk to the patient in determining the level of medical decision making – risk of significant complications, morbidity and mortality – and they recognize three gauges of this r...

In forum Risk Analysis for Medical Devices

4 years ago
RE: What is a risk management file?

A Risk Management File (RMF) is the place where you keep your risk management activities, documentation, and records. It can be structured and organized by an individual product or for a product famil...

In forum Risk Analysis for Medical Devices

4 years ago
RE: What are Design Controls?

To protect patients and users from flaws in design which could have been prevented through thorough documentation and vigilance.

In forum Introduction to Design Controls

4 years ago
RE: Design Verification & Validation

Design Verification is a method to confirm if the output of a designed software product meets the input specifications by examining and providing evidence. The goal of the design verification process ...

In forum Introduction to Design Controls

4 years ago
RE: examples of controlled device changes

The one thing about Quality is paper trail. Documents with a more detailed description on how the design was made, under what circumstances the products are made and all the international regulatory d...

In forum Introduction to Design Controls

4 years ago
RE: Clinical Trials for Today's Vaccine

Its a tough call. At this point, animals aren't really the forefront of the COVID-19 vaccine study. Humans are. We have no real data since everything is done in real time. It is almost like we are exp...

In forum Clinical Research Basics

4 years ago
RE: Ethical Issues with Clinical Trials

I think that using human subjects is a good thing, but post animal testing. Drug testing may not be as effective in humans because they may develop symptoms either mild or life threatening and possibl...

In forum Clinical Research Basics

4 years ago
RE: Researches market Is there a need?

Market research is a vital part of any business strategy, whether that business is B2B or B2C, big or small, new or old. It provides the answers companies need to make decisions that will propel them ...

In forum Marketing and Sales

4 years ago
RE: Manipulation or no?

Marketers who use emotional intelligence to develop highly successful campaigns share these three elements They are honest about their motives for marketing, they deeply empathize with their audience....

In forum Marketing and Sales

4 years ago
RE: Family Businesses

Family business is often conducted with a handshake, but verbal agreements can cause problems. An owner should have a shareholder agreement in place outlining who gets to vote, board member responsibi...

In forum Business 101

4 years ago
RE: The Timing of Approving Medical Devices

Two of the most significant challenges in medical device manufacturing are getting the product to market faster than the competition and meeting high client demands. Larger original equipment manufact...

In forum Regulatory Basics for Medical Devices

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

With a good document control system in place, you can manage access to sensitive documents and restrict them to only the right people at a time. This comes in more so in highly regulated industries wh...

In forum Quality Control and Quality Assurance

4 years ago
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