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Devarshi Joshi posted a new topic "Team Development" – 5 years, 11 months ago
After the development of team how do the execution process works or what does it do during the absence or vacation of an employee or with an personal problem?
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Devarshi Joshi posted a new topic "Medical Devices" – 5 years, 11 months ago
In the execution phase it says about dealing with medical devices during failing of experiments, failing with vendors, failing with regulations, customer demands and while performing new research.
So how would they deal with the failures in such cases?
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Devarshi Joshi posted a new topic "Design Validation" – 5 years, 11 months ago
After looking at the presentation I came across the topic called Design Validation which says that validation checks that inputs are equal to user needs or intended needs. So my question is that does this always happens, does this needs… Read more»
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Devarshi Joshi posted a new topic "Mapping- Gantt Chart" – 5 years, 11 months ago
Gantt Charts are mainly used to convey information visually where they show the order of the events and their timescale. This gives us an overview of starting time and finish time of project which helps in keeping the team informed… Read more»
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Devarshi Joshi posted a new topic "Planning Phase" – 5 years, 11 months ago
If we talk about planning phase in a project of medical devices, according to me one of the important aspect is to find out user needs. Sometimes user needs are bit vague and ambigious but that is considerable. In planning… Read more»
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Devarshi Joshi posted a new topic "Dangerous Syndromes for risk management" – 5 years, 11 months ago
Looking at the process of Risk Management we can find two syndromes : 1) The everything is about risk ploy- It says that they call upon meetings without having new ideas. 2) death by prioritising and analysis. So my question… Read more»
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Devarshi Joshi posted a new topic "Validation and Verification" – 5 years, 11 months ago
Validation is the process of surity that you have objective evidence that are needed by the user and the use of-course. Verification is typically making sure that you are having objective evidence that matches mentioned requirements are meet. This both… Read more»
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Devarshi Joshi posted a new topic "Challenges to Overcome" – 5 years, 11 months ago
As we know that medical devices regulations and processing is more challenging, I would like to discuss some challenges that I thought of like Regulatory Compliance and Securing Funding. Firstly looking at the first challenge Regulator Compliance, as we know… Read more»
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Devarshi Joshi replied to the topic Non Compete Agreement in the forum Consultants and Legal Basics 6 years, 4 months ago
A non-compete clause (NCC), or also called covenant not to compete (CNC), is a clause under which one party mainly employee agrees not to enter into or start a similar profession or trade in competition against another employer. Some courts refer to these as “restrictive covenants.” As a contract provision, a CNC is bound by traditional contract…[Read more]
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Devarshi Joshi replied to the topic NDA vs Patents in the forum Consultants and Legal Basics 6 years, 4 months ago
NDA can be useful when the same person or a company that signed the NDA goes ahead with the idea. When you have a patent, however, and someone replicates whatever is covered by your patent, your prior relationship with that company matters very little. When you have a patent, even people who innocently and coincidentally come out with the same…[Read more]
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Devarshi Joshi replied to the topic Factors to consider when executing the NDA in the forum Consultants and Legal Basics 6 years, 4 months ago
One commonly used tool is the non-disclosure agreement (NDA), also known as a confidential or trade secret agreement. An NDA is a legally binding contract that requires parties to keep confidentiality for a defined period of time. It’s up to the parties to decide what would be considered confidential and what is not. Some of the key elements…[Read more]
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Devarshi Joshi replied to the topic Upper vs Middle Management. in the forum Organizational Development in Device Companies 6 years, 4 months ago
A middle manager is a link between the senior management and junior levels of the organization. Due to involvement into day-to-day running of a business, middle managers have the opportunity to report valuable information and suggestions from the inside of an organization. Moreover, the middle manager is a channel of communication within the…[Read more]
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Devarshi Joshi replied to the topic Matrix Organization- Conflict in the forum Organizational Development in Device Companies 6 years, 4 months ago
It is a type of organizational structure in which people with similar skills are pooled for work assignments, resulting in more than one manager.It does has advantages but also some disadvantages that I would like to talk about. One of the disadvantage is it creates a conflict of loyalty between line managers and project managers over the…[Read more]
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Devarshi Joshi replied to the topic Organization types of medical devices? in the forum Organizational Development in Device Companies 6 years, 4 months ago
Matrix Organization is the practice of managing individuals with more than one reporting line, that means it is a type of organizational structure in which people with similar skills are pooled for work assignments, resulting in more than one manager. I would go with Matrix organization by looking at the key advantages like: it increases…[Read more]
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Devarshi Joshi replied to the topic Risk Identification in the forum Risk Analysis for Medical Devices 6 years, 4 months ago
Severity of harm or risk is classified into three levels, each of which includes a duration
component. The three levels are medical device-related deaths or serious injuries, medical
device-related non-serious adverse events, and medical device-related events without reported
harm.
Medical device-related deaths and serious injuries include those…[Read more] -
Devarshi Joshi replied to the topic Design Documents in Academia in the forum Introduction to Design Controls 6 years, 5 months ago
While working on research you must have lab manual. This document should be clear and concise in format for experiments. It would help as a reference for success and problems that might occur in future and past. Anyway in research documentation is very important. Here is the document that has all the specifications of a project and a device to…[Read more]
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Devarshi Joshi replied to the topic Deviations That Occurs During Verification in the forum Introduction to Design Controls 6 years, 5 months ago
In design controls the verification step is very important. There is high risk factor if the device does not pass verification test. Though I have never personally encountered this kind of problem but, according to me the main issue that would occur is failure in software performance. So as a result there is a malfunction in a device that keeps…[Read more]
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Devarshi Joshi replied to the topic What are Design Controls? in the forum Introduction to Design Controls 6 years, 5 months ago
Set of quality practices and process are defined as design controls. To assure that it meets user needs, intended use and requirements. It monitors and ensures no steps are skipped and enough amount of time is given to each step to complete accurately. Some documents like DID, DSD, etc helps teams clarifying the needs and provide the exact…[Read more]
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Devarshi Joshi replied to the topic Design input sources in the forum Introduction to Design Controls 6 years, 5 months ago
Design inputs are the foundation of medical devices, and so without a strong foundation it would be difficult to bring up the whole product. In a nutshell I would say that design inputs define all performance criteria, requirements, and features of the product. Some goals to considered are: Capture all functional, performance and safety…[Read more]
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Devarshi Joshi replied to the topic Factors to Consider While making Gantt Chart in the forum Introduction to Design Controls 6 years, 5 months ago
Gant Chart can be used to produce an accurate timescale of a project. Though it can also be used to Break down the structure, show their team members how their work relate to others, create a schedule of day to day work, and can also be used in critical path method.
Some things to be considered while making a Gant Chart are: 1)Identifying the…[Read more]
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