Medical device simulation has been found to enhance clinical competence, It has also been found to have many advantages that can improve patient safety and reduce health care costs through the improvement the medical provider competencies. Simulation modeling solves real…   Read more»

Validation should take place from the early to the final stage of our product lifecycle and even after the release to the final solution. Verification and Validation are independent procedures that are used together for checking the project. Verification is…   Read more»

It is critical to understand the important of project initiation phase and how to initiate projects successfully. The project initiation phase is arguably the most important step for enabling success. There are some steps to initiate the projects quickly and…   Read more»

Verification and validation  are  independent procedures that are used together for checking that a product, service, or system meets requirements  and specifications.  Validation : The assurance that a  product service, or system meets the needs of the customer and other…   Read more»

The project initiation phase is the 1st phase in the project life cycle. It is at this point where the opportunity or reason for the project is identified and a project is developed to take advantage of that opportunity. as…   Read more»

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, including intended use and user needs.Design output: including evaluation of conformance to…   Read more»

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 decisions within business. The concept of product life…   Read more»

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 medical devices and radiation – emitting products, FDA develops,…   Read more»

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: – Assigning the wrong person…   Read more»

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 in the supply of medical devices constitutes a priority of…   Read more»

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 manufactures of medical devices. Medical devices are regulated under the Federal Food…   Read more»

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 associated with the device.Class I Devices: Class…   Read more»

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 Control are an important safeguard. FDA…   Read more»

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 planning: Comprehensive planning set up a project…   Read more»

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. Interpersonal skills are the interpersonal acts a person uses to interact with others, Interpersonal…   Read more»

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 which is recognized in the official National Formulary or the United…   Read more»

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 management duties: – Develop a project plan   …   Read more»

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 uses to interact with others effectively. In the business…   Read more»

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, it is not enough to put a group of…   Read more»

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 risk product that promote a healthy lifestyle. CDRH…   Read more»