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  2. Title 21 of the Code of Federal Regulations - Wikipedia

    en.wikipedia.org/wiki/Title_21_of_the_Code_of...

    The 800 series are for medical devices: 803 Medical device reporting; 814 Premarket approval of medical devices [3] 820 et seq. Quality system regulations (analogous to cGMP, but structured like ISO) [4] 860 et seq. Listing of specific approved devices and how they are classified; The 900 series covers mammography quality requirements enforced ...

  3. Medical classification - Wikipedia

    en.wikipedia.org/wiki/Medical_classification

    reimbursement (e.g., to process claims in medical billing based on diagnosis-related groups) knowledge-based and decision support systems; direct surveillance of epidemic or pandemic outbreaks; In forensic science and judiciary settings; There are country specific standards and international classification systems.

  4. Clinical Data Interchange Standards Consortium - Wikipedia

    en.wikipedia.org/wiki/Clinical_Data_Interchange...

    The Clinical Data Interchange Standards Consortium (CDISC) is a standards developing organization (SDO) dealing with medical research data linked with healthcare,made to enable information system interoperability and to improve medical research and related areas of healthcare.

  5. Title 21 CFR Part 11 - Wikipedia

    en.wikipedia.org/wiki/Title_21_CFR_Part_11

    FDA had previously announced that a new Part 11 would be released late 2006. The Agency has since pushed that release date back. The FDA has not announced a revised time of release. John Murray, member of the Part 11 Working Group (the team at FDA developing the new Part 11), has publicly stated that the timetable for release is "flexible".

  6. Medical billing - Wikipedia

    en.wikipedia.org/wiki/Medical_billing

    Several companies also offer full portal solutions through their web interfaces, which negates the cost of individually licensed software packages. Due to the rapidly changing requirements by U.S. health insurance companies, several aspects of medical billing and medical office management have created the necessity for specialized training.

  7. Current Procedural Terminology - Wikipedia

    en.wikipedia.org/wiki/Current_Procedural_Terminology

    The PMAG is composed of performance measurement experts representing the Agency for Healthcare Research and Quality (AHRQ), the American Medical Association (AMA), the Centers for Medicare and Medicaid Services (CMS), the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the National Committee for Quality Assurance (NCQA ...

  8. Clinical data standards - Wikipedia

    en.wikipedia.org/wiki/Clinical_data_standards

    Interoperability between disparate clinical information systems requires common data standards or mapping of every transaction. However common data standards alone will not provide interoperability, and the other requirements are identified in "How Standards will Support Interoperability" from the Faculty of Clinical Informatics [2] and "Interoperability is more than technology: The role of ...

  9. Pharmaceutical Inspection Convention and Pharmaceutical ...

    en.wikipedia.org/wiki/Pharmaceutical_Inspection...

    The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products. [1] [2] The initial members comprised the 10 member countries of EFTA at that time.

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