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2. Qualified Person Responsible For Pharmacovigilance - Wikipedia

   en.wikipedia.org/wiki/Qualified_Person...

   The QPPV must reside in the EU, and should be permanently and continuously at the disposal of the MAH. Each company (i.e. Applicant/Marketing Authorisation Holder or group of Marketing Authorisation Holders using a common pharmacovigilance system) should appoint one QPPV responsible for overall pharmacovigilance for all medicinal products for which the company holds marketing authorisations ...

3. Medical equipment management - Wikipedia

   en.wikipedia.org/wiki/Medical_equipment_management

   Medical equipment management (sometimes referred to as clinical engineering, clinical engineering management, clinical technology management, healthcare technology management, biomedical maintenance, biomedical equipment management, and biomedical engineering) is a term for the professionals who manage operations, analyze and improve utilization and safety, and support servicing healthcare ...

4. UL (safety organization) - Wikipedia

   en.wikipedia.org/wiki/UL_(safety_organization)

   The UL enterprise [4] is a global private safety company headquartered in Northbrook, Illinois, composed of three organizations, UL Research Institutes, UL Standards & Engagement and UL Solutions. Established in 1894, the UL enterprise was founded as the Underwriters' Electrical Bureau (a bureau of the National Board of Fire Underwriters ), [ 5 ...

5. Occupational Safety and Health Administration - Wikipedia

   en.wikipedia.org/wiki/Occupational_Safety_and...

   Compliance Safety and Health Officers carry out inspections and assess fines for regulatory violations. Inspections are planned for worksites in particularly hazardous industries. Inspections can also be triggered by a workplace fatality, multiple hospitalizations, worker complaints, or referrals.

6. Requirements traceability - Wikipedia

   en.wikipedia.org/wiki/Requirements_traceability

   Requirements traceability is a sub-discipline of requirements management within software development and systems engineering.Traceability as a general term is defined by the IEEE Systems and Software Engineering Vocabulary [1] as (1) the degree to which a relationship can be established between two or more products of the development process, especially products having a predecessor-successor ...

7. Regulatory affairs - Wikipedia

   en.wikipedia.org/wiki/Regulatory_affairs

   Regulatory affairs (RA), is a profession that deals with an organization’s adherence to regulatory compliance.. It is a position mostly found within regulated industries, such as pharmaceuticals, medical devices, cosmetics, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare ...