JustinMB

Forum Replies Created

RE: Organization types of medical devices?

At my company I would follow the functional organization chart. It's a form of arrangement that enables seamless cooperation across the flat. I also appreciate the fact that you do not have to answer ...

In forum Organizational Development in Device Companies

3 years ago
RE: Written Agreement v/s Verbal Agreement

A verbal agreement is formed when two or more parties reach an agreement without the use of written documents (known formally as an oral contract). The legality of these verbal agreements, on the othe...

In forum Consultants and Legal Basics

3 years ago
RE: NDA vs Patents

No an NDA is not an substitute for a patent. While an NDA gives you a limited level of protection (which in many cases can easily be bypassed), a patent offers you rock-solid, legally binding, enforce...

In forum Consultants and Legal Basics

3 years ago
RE: Dealing with risk

When dealing with risk, there are some instances where it would it be okay to accept the risk in medical device development. When the benefit of the consumer is greater than that of the risk of releas...

In forum Risk Analysis for Medical Devices

3 years ago
RE: Factors Contributing to Risk Values

Some of factors that could be used to determine risk are "how many individuals would be affected?" "When was the last time the failure happened?" as well as "What is the likelihood of the failure occu...

In forum Risk Analysis for Medical Devices

3 years ago
RE: Benefits of post-market surveillance

Post-market surveillance is very beneficial as it allows companies to see the long term results of their product as well as how they affect the consumer in their daily life. Post data can offer valuab...

In forum Risk Analysis for Medical Devices

3 years ago
RE: Design Verification Ethics

I feel as though many companies are guilty of this to some extent. Maybe they need the product out now for revenue and they feel they can fix what they missed in an update or they feel as though the p...

In forum Introduction to Design Controls

3 years ago
RE: Medical Device Clinical Trials vs Drug Trials

As you said, both have many similarities however there are some differences. Drug trials are testing for safety and tolerability along with pharmacokinetics; medical device trials are mainly checking ...

In forum Introduction to Design Controls

3 years ago
RE: Consequences Of Insufficient Design Controls

Without proper design controls the whole project is in high jeopardy of failing. The product/device can be missing requirements or be built improperly or may even be harmful to the patient its suppose...

In forum Introduction to Design Controls

3 years ago
RE: Clinical Studies

There certainly are advantages and disadvantages to clinical test. An advantage is that we have ways to test if drugs or devices are suitable for sale and public use. A disadvantage is how dangerous s...

In forum Clinical Research Basics

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

I believe the use of PCTs are ethical as well as necessary. Placebos allow studies to have a control they can test against the baseline of a patient/participant. Thanks to placebos we can see if a cha...

In forum Clinical Research Basics

3 years ago
RE: Where to Find Historical Clinical Trials?

You can find the results for different clinical trials online for medications, medical devices, etc. Clinicaltrials.gov offers key facts about registered trials, including study design, administrative...

In forum Clinical Research Basics

3 years ago
RE: Discussion Topic: The Fifth "P" of Marketing

Engagement and participation are a major part of almost any brand. The most common way of Participation in todays society is social media. Different companies and sites have accounts on different soci...

In forum Marketing and Sales

3 years ago
RE: Advertising

I agree advertisement is a =n important part of almost any brand, business, or company. A promotion and advertisement that comes to mind when thinking of successful commercials are the late 90s and ea...

In forum Marketing and Sales

3 years ago
RE: Brand Coloring

Coloring is an important component to think about when branding a product/company. Many colors have inherent meanings people tend to associate with them. This is an essential consideration because peo...

In forum Marketing and Sales

3 years ago
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