Medical deviceA medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases.
Project managementProject management is the process of leading the work of a team to achieve all project goals within the given constraints. This information is usually described in project documentation, created at the beginning of the development process. The primary constraints are scope, time, and budget. The secondary challenge is to optimize the allocation of necessary inputs and apply them to meet pre-defined objectives. The objective of project management is to produce a complete project which complies with the client's objectives.
Project managerA project manager is a professional in the field of project management. Project managers have the responsibility of the planning, procurement and execution of a project, in any undertaking that has a defined scope, defined start and a defined finish; regardless of industry. Project managers are first point of contact for any issues or discrepancies arising from within the heads of various departments in an organization before the problem escalates to higher authorities, as project representative.
Project stakeholderProject stakeholders are persons or entities who have an interest in a given project. According to the Project Management Institute (PMI), the term project stakeholder refers to "an individual, group, or organization, who may affect, be affected by, or perceive itself to be affected by a decision, activity, or outcome of a project, program, or portfolio. ISO 21500 uses a similar definition.
ProjectA project is any undertaking, carried out individually or collaboratively and possibly involving research or design, that is carefully planned to achieve a particular goal. An alternative view sees a project managerially as a sequence of events: a "set of interrelated tasks to be executed over a fixed period and within certain cost and other limitations". A project may be a temporary (rather than a permanent) social system (work system), possibly staffed by teams (within or across organizations) to accomplish particular tasks under time constraints.
Project planA project plan, according to the Project Management Body of Knowledge (PMBOK), is: "...a formal, approved document used to guide both project execution and project control. The primary uses of the project plan are to document planning assumptions and decisions, facilitate communication among project stakeholders, and document approved scope, cost, and schedule baselines. A project plan may be sumarized or detailed.
Biomedical equipment technicianA biomedical engineering/equipment technician/technologist (BMET) or biomedical engineering/equipment specialist (BES or BMES) is typically an electro-mechanical technician or technologist who ensures that medical equipment is well-maintained, properly configured, and safely functional. In healthcare environments, BMETs often work with or officiate as a biomedical and/or clinical engineer, since the career field has no legal distinction between engineers and engineering technicians/technologists.
Clinical trialClinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought.
Project initiation documentationThe project initiation documentation (PID) is one of the most significant artifacts in project management, which provides the foundation for the business project. The project initiation documentation bundles the information, which was acquired through the starting up a project (SU) and initiating a project (IP) processes in a PRINCE2 controlled project environment. PRINCE2's 2009 renaming "document" to "documentation" indicates a collection of documentation that has been collected up creating a project rather than all the information in the system.
HealthIn common usage and medicine, health, according to the World Health Organization, is "a state of complete physical, mental and social well-being and not merely the absence of disease and infirmity". A variety of definitions have been used for different purposes over time. Health can be promoted by encouraging healthful activities, such as regular physical exercise and adequate sleep, and by reducing or avoiding unhealthful activities or situations, such as smoking or excessive stress.
