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Nikhil Nagarjun replied to the topic "Alternatives dispute resolution" – 4 years, 4 months ago
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 allows for more creative and collaborative solutions than that of traditional litigation.
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Nikhil Nagarjun replied to the topic "NDA vs Patents" – 4 years, 4 months ago
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 (NDA), the parties agree to keep certain… Read more»
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Nikhil Nagarjun replied to the topic "Written Agreement v/s Verbal Agreement" – 4 years, 4 months ago
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 the actions of the parties… Read more»
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Nikhil Nagarjun replied to the topic "Medical Device Project" – 4 years, 4 months ago
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… Read more»
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Nikhil Nagarjun replied to the topic "Forming a Project Team" – 4 years, 4 months ago
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-management positions, both professional abilities and soft… Read more»
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Nikhil Nagarjun replied to the topic "Discussion Topic: Your organizational type" – 4 years, 4 months ago
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 allows individuals from different functions… Read more»
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Nikhil Nagarjun replied to the topic "Risk Management Tools" – 4 years, 4 months ago
There are many tools and techniques for Risk identification. Documentation Reviews Information gathering techniques Brainstorming Delphi technique – here a facilitator distributes a questionnaire to experts, responses are summarized (anonymously) & re-circulated among the experts for comments. This technique is… Read more»
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Nikhil Nagarjun replied to the topic "Dealing with risk" – 4 years, 4 months ago
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. Risk management isn’t reactive only; it… Read more»
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Nikhil Nagarjun replied to the topic "Risk management methods" – 4 years, 4 months ago
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 absorb more effort than the benefit they deliver. It is… Read more»
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Nikhil Nagarjun replied to the topic "Minutes for meetings" – 4 years, 5 months ago
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. Minutes that capture the purpose of… Read more»
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Nikhil Nagarjun replied to the topic "When is validation is not required?" – 4 years, 5 months ago
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 validation testing is to demonstrate that the… Read more»
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Nikhil Nagarjun replied to the topic "What are Design Controls?" – 4 years, 5 months ago
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 control that the… Read more»
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Nikhil Nagarjun replied to the topic "Important Part of DDP" – 4 years, 5 months ago
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 company itself, and create a development budget that will… Read more»
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Nikhil Nagarjun replied to the topic "Design Transfer" – 4 years, 5 months ago
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 unavailable or higher in cost than expected, production workflow… Read more»
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Nikhil Nagarjun replied to the topic "Consequences Of Insufficient Design Controls" – 4 years, 5 months ago
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 all Class II and III… Read more»
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Nikhil Nagarjun replied to the topic "Clinical Studies" – 4 years, 5 months ago
Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has… Read more»
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Nikhil Nagarjun replied to the topic "Ethical Issues with Clinical Trials" – 4 years, 5 months ago
The practice of medicine sometimes involves situations where important values come into conflict. The refusal of life-saving treatment, the concern that telling the truth could have problematic consequences, acceptable ways of facing a request to die all are examples of… Read more»
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Nikhil Nagarjun replied to the topic "WHAT IS THE OBJECTIVE OF CLINICAL TESTING ON PHARMACEUTICA DRUGS?" – 4 years, 5 months ago
The point about curing might be true in most of the cases .But clinical trials are not just about curing ,it is also about the safety of using the drug .In most cases it may not do the magic ,but… Read more»
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Nikhil Nagarjun replied to the topic "Discussion Topic: Mission and Vision statements" – 4 years, 5 months ago
A Mission statement talks about HOW you will get to where you want to be. Defines the purpose and primary objectives related to your customer needs and team values. A Vision statement outlines WHERE you want to be. Communicates both… Read more»
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Nikhil Nagarjun replied to the topic "WHAT IS MARKETING TO YOU?" – 4 years, 5 months ago
Simply put Marketers are the brains behind getting the word out about their organization’s products or services.
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