hg93 | Medical Device Courses

hg93 replied to the topic "Alternatives dispute resolution" – 5 years, 11 months ago

Hi, Here are other few, out of court dispute resolutions which are referred to as Alternative Dispute Resolution (ADR). Minitrials A minitrial is a process by which the attorneys for the parties present a short version of the case to… Read more»
hg93 replied to the topic "Anti-kickback & Stark Cases" – 5 years, 11 months ago

Under the Anti-Kickback Statute, a company commits fraud when it offers doctors and other health care providers financial incentives to use the business’s products or services, for which payment may be made under Medicare, Medicaid or other federally-funded healthcare programs…. Read more»
hg93 replied to the topic "Written Agreement v/s Verbal Agreement" – 5 years, 11 months ago

Krunal, Nice discussion topic! The term ‘verbal contract’ actually refers to any agreement which can be expressed in words, and that means all written contracts as well as those that have only been discussed. The major practical differences between ‘oral… Read more»
hg93 replied to the topic "Organization Type vs. Effectiveness" – 5 years, 11 months ago

This is a good discussion topic related to the organizational structure. According to PMBOK, organizational structure is defined as an enterprise environmental factor which affects the availability of resources and influences how the projects are conducted. As discussed by Dr…. Read more»
hg93 replied to the topic "Manage Risk" – 5 years, 11 months ago

One of the points for avoiding risk I would like to add to manage risk is Exploitation. Exploitation: To exploit the risk. The techniques mentioned above are great when they have a negative impact in the project but what if… Read more»
hg93 replied to the topic "Factors Contributing to Risk Values" – 5 years, 11 months ago

Risk index number = impact of risk event x probability of occurrence The impact of the risk event is commonly assessed on a scale of 1 to 5, where 1 and 5 represent the minimum and maximum possible impact of… Read more»
hg93 replied to the topic "Combination Product Phase I clinical Studies" – 5 years, 11 months ago

Design plans are just a plan. In fact, this is stated in both Clause 7.3.1 of the ISO Standards, and in Section 21 CFR 820.30b of the FDA QSR.Design control for 1st phase include the following 16 tasks: Identification of… Read more»
hg93 replied to the topic "Design Verification & Validation" – 5 years, 11 months ago

Great discussion so far! Verification and validation are two critical elements of product development. One informs the elements of a product’s design, while the other looks at those design elements in the hands of users. Although often used synonymously, these… Read more»
hg93 posted a new topic "Collaboration projects" – 5 years, 11 months ago

As Dr.Simon mentioned, there are several types of organizational structure which a company can function within, each having their own set of advantages and disadvantages. Consider collaboration projects, that is, two or more companies come together to develop and manufacture… Read more»
hg93 posted a new topic "Organizational structure and Culture both leading to project success?" – 5 years, 11 months ago

As Dr.Simon have mentioned there are different types of organizational structures. Any project is affected by project management system, culture, style, organizational structure and also project management office can influence the project.According to me, organizational structure is responsible for organizational… Read more»
hg93 posted a new topic "Risk Management – Identification" – 5 years, 11 months ago

Risk management is the process of analyzing, identifying and responding to risk factors throughout the course of the project. Managing risks early on in the project is the best way to avoid project catastrophes. Continuously applying the right risk management… Read more»
hg93 posted a new topic "Design Transfer" – 5 years, 11 months ago

As discussed closing phase is one of the most critical aspects of a project and can sometimes be looked at as a project of its own. Dr. Simon this week discussed the basis of the Design Transfer, an important part… Read more»
hg93 posted a new topic "Design Review Meetings" – 5 years, 11 months ago

As mentioned in the lecture, design review meetings happen at the end of each stage in the project. They are critical because they facilitate communication between the design team, management, and the customer. The design team provides information about the… Read more»
hg93 posted a new topic "Important Part of DDP" – 5 years, 11 months ago

Design Development Plan (DDP) contains: *final scope statement *scope management plan *quality management plan *communications management plan *team member list/responsibilities Communication management plan is the most important part of the DDP because communication management plan contains information on how to… Read more»
hg93 posted a new topic "What are Design Controls?" – 5 years, 11 months ago

“Design Controls” is a FDA term and defined in FDA 21 CFR 820.30. Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied to control design activities while assessing quality and correcting errors through… Read more»
hg93 replied to the topic Alternatives dispute resolution in the forum Consultants and Legal Basics 8 years, 4 months ago

Hi,

Here are other few, out of court dispute resolutions which are referred to as Alternative Dispute Resolution (ADR).

Minitrials

A minitrial is a process by which the attorneys for the parties present a short version of the case to a panel, often comprised of the clients themselves and a neutral intermediary who chairs the process. Expert…[Read more]
hg93 replied to the topic Anti-kickback & Stark Cases in the forum Consultants and Legal Basics 8 years, 4 months ago

Under the Anti-Kickback Statute, a company commits fraud when it offers doctors and other health care providers financial incentives to use the business’s products or services, for which payment may be made under Medicare, Medicaid or other federally-funded healthcare programs. The illegal kickbacks can be cash payments, but often include other i…[Read more]
hg93 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics 8 years, 4 months ago

Krunal,
Nice discussion topic!

The term ‘verbal contract’ actually refers to any agreement which can be expressed in words, and that means all written contracts as well as those that have only been discussed. The major practical differences between ‘oral contracts’ and ‘written’ ones are to refer to a contract that’s only spoken about; it’s…[Read more]
hg93 started the topic Collaboration projects in the forum Organizational Development in Device Companies 8 years, 5 months ago

As Dr.Simon mentioned, there are several types of organizational structure which a company can function within, each having their own set of advantages and disadvantages. Consider collaboration projects, that is, two or more companies come together to develop and manufacture a product.

In your opinion,which organizational structure would be more…[Read more]
hg93 started the topic Organizational structure and Culture both leading to project success? in the forum Organizational Development in Device Companies 8 years, 5 months ago

As Dr.Simon have mentioned there are different types of organizational structures. Any project is affected by project management system, culture, style, organizational structure and also project management office can influence the project.According to me, organizational structure is responsible for organizational culture.It plays a significant…[Read more]
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