Alternative Dispute Resolution (ADR) is a spectrum of less costly and more expeditious alternatives to litigation, where a neutral party assists the disputing parties in reaching resolution. ADR allow...

To answer the above it is important to know what is NDA. In business relationships, one or both parties may want to make sure some information stays confidential. By signing a non-disclosure agreement...

The only problem with verbal contracts is the fact that their existence (and their particulars) can be difficult to prove. So, how can you prove that the contract ever existed? You can do this through...

Even though we know our roles it is still confusing and a lot figure out ,but working in a team is fun and a good experience as it gives us the ideal how a real project works. In our project my experi...

This is something that could be answered in different fronts one might say Bringing the right people on board is another thing to handle before kicking off a new project. For management and non-manage...

I would like to work under matrix type of organization as it is ideal place to work in terms of sharing talent and skills across departments. It's an handy system when developing new products ,it all...

There are many tools and techniques for Risk identification. Documentation Reviews Information gathering techniques Brainstorming Delphi technique – here a facilitator distributes a questionnaire to ...

Project risk management is the process of identifying, analyzing and then responding to any risk that arises over the life cycle of a project to help the project remain on track and meet its goal. Ris...

There are several methods of project risk management in common use. Some are extremely cost-effective but the subject still attracts a lot of muddled thinking and well-intentioned efforts that can abs...

Most of us have attended a meeting madly scribbling what we thought were meeting minutes only to find out later that we’ve missed important information of that the notes we took were never used. Minut...

The completion of process validation is a regulatory requirement that a manufacturer must adhere to. But in some cases as mentioned above the validation is not required .The main goal of human factors...

Design controls are the means a medical device developer uses to prove that a product is safe, it works, and it is suited to the needs of the market. The following are points that justified by design ...

The purpose of the design and development plan section is to provide investors with a description of the product's design, chart its development within the context of production, marketing, and the co...

It is important to understand couple of things when it comes to design transfer that is Inability to transfer a design effectively can prompt circumstances in which determined parts are either unavail...

While design control is not required for all medical devices, it applies to nearly every medium- and high-risk device. And this isn’t just for new devices – in the US, FDA requires design controls for...