gsharma

Forum Replies Created

RE: Public vs. Private Companies

As mentioned by ih37, the biggest difference between a public company and private company is that you could buy shares of the public company and the company is required to file quarterly earnings repo...

In forum Business 101

7 years ago
RE: Partnership characteristics

I would consider someone for business partnership if I am able to trust them and their ability to handle the business. I will consider them if he/she shares the same professional values, ideas and goa...

In forum Business 101

7 years ago
RE: Types of Corporations

I would like to be part of General Partnership Corporation where 2 or more people are involved in starting a business and contributing money, skills and labor towards the business. General partnership...

In forum Business 101

7 years ago
RE: Good Quality Control or Quality Assurance Department

Quality Control controls the quality of the product to ensure customer requirements and needs are meet and Quality Assurance assures that quality requirements will be meet based on customers, FDA, reg...

In forum Quality Control and Quality Assurance

7 years ago
RE: Relation of Quality with other department.

I think one of the way to have better relationship within the departments is to improve communication and ways of communication. Departments should realize that they are working for the same company t...

In forum Quality Control and Quality Assurance

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

Document control is an important method that refines the document management system. Document control reduces documentation error and ensures that the data is searchable, information is secured and do...

In forum Quality Control and Quality Assurance

7 years ago
RE: Precision and Accuracy

It is very important that the medical devices actually do what it says it will do. This is one of the requirement in the medical device amendments of 1976 that the medical device must be safe, effecti...

In forum Regulatory Basics for Medical Devices

7 years ago
RE: FDA on Recalled Items

There is a list of drugs on FDA website that have been recalled to protect public health from defective or potential harmful product. Some on the products included on the list are: Nasal Products, Bab...

In forum Regulatory Basics for Medical Devices

7 years ago
RE: FDA rules too strict?

The FDA has to be very strict to protect public health by regulations to oversee food, drugs, cosmetics and medical devices. It is true that lenient FDA regulations could increase innovation in techno...

In forum Regulatory Basics for Medical Devices

7 years ago
RE: Animals Used in Animal Testing

Scientist know that there’s an ethical concern with animal testing and they have widely accepted the three Rs ethical principal for Replacement, Reduction and Refinement. Reduction: reducing the numbe...

In forum Pre-clinical Device Development

7 years ago
RE: Discussion Topic: Brand new biomaterial

As mentioned before, biocompatibility testing must be performed in accordance to ISO 10993 and other FDA relevant standards. The type of testing depends on the type of device: surface, external or imp...

In forum Pre-clinical Device Development

7 years ago
RE: Ethics of Animal Testing

It is unethical to perform animal testing however that is the optimum way as test subject to gain knowledge about potential human treatments. Animal study and experimentation can be very useful for ad...

In forum Pre-clinical Device Development

7 years ago
RE: Multiple Project Managers for one project

I have never heard of multiple project managers for the same project. There can only be one project manager per project. There are department managers involved in multiple projects or one project mana...

In forum Intro to Project Management

7 years ago
RE: Work Breakdown Structure(WBS)

The work breakdown structure represents all products and project work. It shows the total work from lowest levels to the highest levels so that nothing is left out and no extra work is completed. The ...

In forum Intro to Project Management

7 years ago
RE: Discussion Topic: Project Management in a medical device setting

Project manager faces many challenges in medical device industry compared to project manager involved in construction of a school or skyscraper. Project manager in medical device industry faces increa...

In forum Intro to Project Management

7 years ago
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