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td256 replied to the topic "NDA vs Patents" – 5 years, 4 months ago
Patents represent rock-solid proof of ownership of an idea. And this is important because an idea is intangible. There are only two ways a court of law recognizes ownership of an idea – NDA and Patent. Whereas a patent is a federal… Read more»
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td256 replied to the topic "Written Agreement v/s Verbal Agreement" – 5 years, 4 months ago
From a practical standpoint, having a written agreement is a way of “vetting” the opposing side. Writing a formal agreement involves the review and assistance of legal counsel during the contract formation process. The act of preparing and negotiating a… Read more»
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td256 replied to the topic "Advice before signing an NDA" – 5 years, 4 months ago
It is important that you understand the terms of the agreement of NDA before signing it. NDAs generally contain a few specific pieces:Definitions of confidential informationObligations from all involved people or partiesTime periodsBe cautious of an overbroad agreement that seems… Read more»
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td256 replied to the topic "Upper vs Middle Management." – 5 years, 4 months ago
Most organizations have three management levels: first-level, middle-level, and top-level managers. These managers are classified according to a hierarchy of authority and perform different tasks. Middle management is the intermediate leadership level of a hierarchical organization, being subordinate to the… Read more»
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td256 posted a new topic "Malsow's law in organization" – 5 years, 4 months ago
Abraham Maslow, a psychologist from the behavioral era of management history, proposed a theory of motivation based on universal human needs. Maslow believed that each individual has a hierarchy of needs, consisting of physiological, safety, social, esteem, and self-actualization needs.Physiological… Read more»
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td256 replied to the topic "Medical Device Project" – 5 years, 4 months ago
It is interesting that you pointed out how we’re working in martix type organization. Our team has the first meeting on last Friday and we have decided to keep Fridays fixed for our weekly meeting. As we all weren’t aware… Read more»
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td256 posted a new topic "Benefits of post-market surveillance" – 5 years, 4 months ago
To make sure medical devices remain safe and effective once it’s on the market – medical post-market surveillance (PMS) is done. It a system that provides continuous feedback about a device on the market in order to maintain a high… Read more»
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td256 posted a new topic "SWOT analysis for risk management" – 5 years, 4 months ago
SWOT analysis is one of the techniques organizations use for risk management of their products. SWOT stands for Strengths Weaknesses, Opportunities, and Threats. The organizations employ the SWOT analysis to forecast, identify, resolve and guard against pending seen and unforeseen… Read more»
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td256 posted a new topic "ISO 14971 standard in risk management" – 5 years, 4 months ago
As of now, governments do not have own guidelines for performing risk management. They refer to ISO 14971, the global standard for medical device risk management. The intent of the standard is to identify hazards associated with medical devices at… Read more»
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td256 posted a new topic "Steps of Process Validation" – 5 years, 4 months ago
Design validation focuses on the device itself and involves creating evidence that it meets user needs and intended uses. Process validation, as the name implies, focuses on the production of the device. Most companies follow FDA requirements for design control… Read more»
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td256 replied to the topic "What are Design Controls?" – 5 years, 4 months ago
Medical devices used in the United States must comply with federal regulations established to ensure that specified requirements have been met. A high-level overview of these design control requirements is provided to increase awareness of the device development process and… Read more»
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td256 replied to the topic "Design Controls in the other countries" – 5 years, 4 months ago
Investment in artificial intelligence (AI) and digital health technologies has increased exponentially over the last few years. In the United Kingdom, the excitement and interest in this space has been supported by NHS policies, including proposals in the NHS Long… Read more»
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td256 posted a new topic "examples of controlled device changes" – 5 years, 5 months ago
Product development is inherently an evolutionary process. While change is a healthy and necessary part of product development, quality can only be maintained if those changes are controlled and documented. Design control involves establishing procedures to identify, document, review, verify,… Read more»
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td256 posted a new topic "Medical Device Clinical Trials vs Drug Trials" – 5 years, 5 months ago
Clinical trials for medical devices have many similarities to drug trials, there are some necessarydifferences in the way the trials are designed and carried out. And in some cases, for medical devices, clinical trials may not even be required. Clinical… Read more»
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td256 replied to the topic "Combination Product Phase I clinical Studies" – 5 years, 5 months ago
The design control requirements are basic controls needed to ensure that the device being designed will perform as intended when produced for commercial distribution. The elements of design controls are – planning, input, output, review, verification, validation, transfer, design changes… Read more»
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td256 replied to the topic "Double Blind Vs Single blind Study" – 5 years, 5 months ago
In a clinical trial, the two major models are single blind and double blind trials. Human behavior is influenced by what we know or believe. In research there is a particular risk of expectation influencing findings leading to biased results…. Read more»
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td256 replied to the topic "Clinical Studies" – 5 years, 5 months ago
Before clinical trial a drug or medical device cannot go into the market. Clinical trial has unavoidable moral conflict which cannot be solved permanently. Without clinical trial we won’t know the good or bad effects of the drug or device…. Read more»
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td256 replied to the topic "Clinical Trial Roles" – 5 years, 5 months ago
I want to be an investigator in clinical research trial. By being n investigator I will be directly in touch with the subjects and involved in the research methods. Being in a lab/research environment excites me. Seeing the results and… Read more»
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td256 posted a new topic "Sales vs project management" – 5 years, 5 months ago
The missions of sales and product management are very different. Sales is associated with quarterly and annual targets and incentives. Whereas product management is related to the product lifecycle, market share, and competitive positioning. In reality, product management and sales… Read more»
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td256 replied to the topic "Medical Device SWOT Analysis" – 5 years, 5 months ago
I am choosing Edwards Lifesciences for SWOT analysis :STRENGTH1. largest maker of heart valves2. strong free cash flow to expand into new peoducts3. increases R&D gives competitive aadvantage4. high level of customer satisfaction5. strong brand portfolio WEAKNESS1. need more invest in… Read more»
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