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Sam Doksh
@sam-doksh
Estimable Member
Joined: Sep 3, 2019
Last seen: Apr 27, 2020
Topics: 4 / Replies: 110
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RE: Design Control Process

FDA has required that medical device that want to market certain categories of medical devices in the UISA follow Design Control requirements. Design ...

5 years ago
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RE: Product Life Cycle

Product life cycle management is the succession of strategies by business management as a product goes through its life cycle. The life cycle of a pro...

5 years ago
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RE: FDA Regulations of Medical Device-Drug

FDA legal authority to regulate both medical devices and electronic radiation- emitting products in the federal Food Drug& Cosmetic Act. To fulfil...

5 years ago
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RE: How To Avoid Repeated Mistakes in A Project Management Team?

Mistakes happen, How a team deals with and learn from them is what determines if the team will eventually become a winning team. There are some common...

5 years ago
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RE: Determining project priority

The main objective of the priority Medical Device project was to identify gaps in the availability of preventive, diagnostic, therapeutic and assistiv...

5 years ago
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RE: Possibility of Global Regulation of Medical Devices?

The FDA regulates food, drugs, medical devices, biologics, cosmetics and radiation emitting products in the USA. FDA Center of Devices and Radiologica...

5 years ago
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RE: Categorization of Medical Devices

FDA classifies medical devices, There are three main classifications Class |, Class || , and Class |||. The assignment of a classification for a devic...

5 years ago
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RE: New Medical Device Project

The majority of medical device must be developed under the FDA Design Controls. Design Control are the means by which the FDA validates the safety and...

5 years ago
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RE: Project Manager Skills

Success of project manager depends on a number of factors: 1- Smart people: Without the right team in place, any strategy and plan has the potential ...

5 years ago
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RE: Interpersonal skills vs technical knowledge

Interpersonal Skills is any competence facilitating interaction and communication with others where social rules and relations are created, communicat...

5 years ago
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RE: Medical device

The FDA defines a medical device as: an instrument, apparatus, implement, machine, contrivance, implant, in vitro regent, or other similar or related ...

5 years ago
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RE: Project management team

Successful projects are usually the result of careful planning and the talent and collaboration of a project team members, Projects can not move forwa...

5 years ago
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RE: Interpersonal Skills

Interpersonal Skills are the skills we use every day when we communicate and interact with other people, both individually and in groups. Interpersona...

5 years ago
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RE: Ideal project team

Ideal project team support one another and provide the ideas and action required to follow a project through to completion. Building a team who can su...

5 years ago
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RE: General Wellness Product

The Food and Drug Administration (FDA) is issuing this guidance document to provide clarity to industry and FDA staff on the Center for Devices and Ra...

5 years ago
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