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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.
HCPCS includes three levels of codes: Level I consists of the American Medical Association's Current Procedural Terminology (CPT) and is numeric.; Level II codes are alphanumeric and primarily include non-physician services such as ambulance services and prosthetic devices, and represent items and supplies and non-physician services, not covered by CPT-4 codes (Level I).
The CPT code set describes medical, surgical, and diagnostic services and is designed to communicate uniform information about medical services and procedures among physicians, coders, patients, accreditation organizations, and payers for administrative, financial, and analytical purposes.
Such regulations generally require keeping track of what treatments are provided to patients and for what reason, and medical coding is a standardized way of record such information (and sharing it with third parties, such as insurers). Optimal coding compliance results in higher revenues and decreases claim denials from insurance companies.
IEC TR 60930 Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems IEC 60931 Shunt power capacitors of the non-self-healing type for a.c. systems having a rated voltage up to and including 1000 V
Regulatory compliance in the European Union (EU) is governed by a harmonized legal framework designed to ensure consistency across member states while allowing for national implementation. EU compliance regulations cover various industries, including consumer product safety, financial services, environmental protection, and data privacy.
HCPCS Level II codes are alphanumeric medical procedure codes, primarily for non-physician services such as ambulance services and prosthetic devices. [1] They represent items, supplies and non-physician services not covered by CPT-4 codes (Level I). Level II codes are composed of a single letter in the range A to V, followed by 4 digits.
Compliance requirements are only guidelines for compliance with the hundreds of laws and regulations applicable to the specific type assistance used by the recipient, and their objectives are generic in nature due to the large number of federal programs. [1] Each compliance requirement is identified by a letter, in alphabetical order.