FDA has required that medical device that want to market certain categories of medical devices in the UISA follow Design Control requirements. Design and development planning . Design input, includin...

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 product is associated with marketing and management d...

FDA legal authority to regulate both medical devices and electronic radiation- emitting products in the federal Food Drug& Cosmetic Act. To fulfill the provision of the FD&C Act that apply to ...

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 project management mistakes and how to avoid them...

The main objective of the priority Medical Device project was to identify gaps in the availability of preventive, diagnostic, therapeutic and assistive medical devices on the market. Mapping of gaps i...

The FDA regulates food, drugs, medical devices, biologics, cosmetics and radiation emitting products in the USA. FDA Center of Devices and Radiological Health (CDRH) is responsible for regulating manu...

FDA classifies medical devices, There are three main classifications Class |, Class || , and Class |||. The assignment of a classification for a device depends upon the level of risk that is associate...

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 efficacy of medical devices on the market. Design...

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 of completely falling apart. 2- Smart plannin...

Interpersonal Skills is any competence facilitating interaction and communication with others where social rules and relations are created, communicated, and changed in verbal and nonverbal ways. Inte...

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

Successful projects are usually the result of careful planning and the talent and collaboration of a project team members, Projects can not move forward without each of its key team members. Project m...

Interpersonal Skills are the skills we use every day when we communicate and interact with other people, both individually and in groups. Interpersonal Skills are the behaviors and tactics a person us...

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 successfully collaborate is not without challenges, ...

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 Radiological Health (CDRH) compliance policy for low...