anvitha

Forum Replies Created

RE: Non Compete Agreement

In contract law, a non-compete clause (often NCC), or covenant not to compete (CNC), is a clause under which one party (usually an employee) agrees not to enter into or start a similar profession or t...

In forum Consultants and Legal Basics

4 years ago
RE: NDA vs Patents

The difference is that a patent is a federal document proving ownership of an idea, and an NDA is simply a contract between two people. NDA is a contract and not a law. Contracts are interpreted in di...

In forum Consultants and Legal Basics

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

I agree with the previous posts mentioning that a written contract is more useful and reliable than a verbal agreement. Verbal contracts are extremely difficult to defend in court as it is difficult t...

In forum Consultants and Legal Basics

4 years ago
RE: Forming a Project Team

In the real world scenario, we usually do not pick who we end up working with and it always best to work with those who have the right skill set to do the job and project needed. This is also because ...

In forum Organizational Development in Device Companies

4 years ago
RE: Organization Type vs. Effectiveness

I agree that a composite organization will be best suited since it allows a company to blend the functional, matrix, and project-based types of organizations to help suit the company requirements. Thi...

In forum Organizational Development in Device Companies

4 years ago
RE: Organization types of medical devices?

I think that the matrix organization structure would be the best for most companies. It provides a well-balanced structure as the employees have to report to at least two bosses - their functional man...

In forum Organizational Development in Device Companies

4 years ago
RE: Manage Risk

Proper risk management implies control of possible future events and is proactive rather than reactive. For low severity risks, acceptance or mitigation needs to be done. If the benefit is worth the s...

In forum Risk Analysis for Medical Devices

4 years ago
RE: Risk Management Mistakes

This is an interesting discussion, thank you for sharing it! I think a major mistake is to assume that one is only looking for extreme and catastrophic risks and therefore overlooking smaller less out...

In forum Risk Analysis for Medical Devices

4 years ago
RE: Benefits of post-market surveillance

I think PMS is very important for newer devices or those of Class II or higher because these devices tend to be of newer technology where all of the risks can not be covered during the design phase. I...

In forum Risk Analysis for Medical Devices

4 years ago
RE: a successful validation process

A successful validation program brings together engineering, manufacturing, regulatory compliance, and quality assurance to develop test solutions that are unique to each application. Developers of me...

In forum Introduction to Design Controls

4 years ago
RE: Why VERIFICATION is important? and Your ideas to improve Verification process ?

Verification is the process of ensuring that objective evidence is present and that the specific requirements are met. Any unforeseen side effects that it may have can also be recognized. This early d...

In forum Introduction to Design Controls

4 years ago
RE: Minutes for meetings

Although I am somebody who has the habit of making notes proactively during a meeting, I think meeting minutes are important just so I can cross-check in case there's something I have missed out on. T...

In forum Introduction to Design Controls

4 years ago
RE: Design Transfer

The benefits of outsourcing the design transfer into the manufacturing process are leveraging multidisciplinary expertise to have breakthrough ideas from other industries and technologies and be able ...

In forum Introduction to Design Controls

4 years ago
RE: Customer Needs and Design Input

A design specification document (DSD)is a detailed document that provides information about a designed product or process. The design specification must include all necessary drawings, dimensions, env...

In forum Introduction to Design Controls

4 years ago
RE: Consequences Of Insufficient Design Controls

The different areas of the Design Controls allow for each section of the project to be organized and ensure the product released is of the highest quality. Without design controls, the company is runn...

In forum Introduction to Design Controls

4 years ago
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