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  • 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»

  • 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»

  • 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»

  • 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»

  • 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»

  • 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»

  • 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»

  • 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»

  • 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»

  • 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»

  • 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»

  • 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»

  • 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»

  • 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»

  • 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»

  • 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»

  • 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»

  • 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»

  • 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»

  • 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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