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The duration of the SPC can, however, be extended to 5.5 years when the SPC relates to a human medicinal product for which data from clinical trials conducted in accordance with an agreed Paediatric Investigation Plan (PIP) have been submitted (as set out in Article 36 of Regulation (EC) No 1901/2006 [2]).
The SPC is not intended to give general advice about treatment of a condition but does state how the product is to be used for a specific treatment. It forms the basis of information for health professionals to know how to use the specific product safely and effectively. The package leaflet supplied with the product is aimed at end-users. [3]
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
The health information legislation established the rules that must be followed for the collection, use, disclosure and protection of health information by healthcare workers known as "custodians". These custodians have been defined to include almost all healthcare professionals (including all physicians, nurses, chiropractors, operators of ...
A more sophisticated SPC chart may include "control limit" & "spec limit" % lines to indicate whether/what action should be taken. Statistical process control (SPC) or statistical quality control (SQC) is the application of statistical methods to monitor and control the quality of a production process. This helps to ensure that the process ...
The Healthcare Sterile Processing Association (HSPA), formerly International Association of Health Central Service Material Management (IAHSCMM), [3] is a professional association which represents healthcare Central Service (CS) professionals, and is based in Chicago, Illinois with over 48,000 [4] members worldwide.
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Discovering that patient safety had become a frequent topic for journalists, health care experts, and the public, it was harder to see overall improvements on a national level. What was noteworthy was the impact on attitudes and organizations. Few health care professionals now doubted that preventable medical injuries were a serious problem.