What do you mean by Good documentation practice (GDP)? Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from “good distribution practice” also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDP / GDocP standards ..
Background Though it is tailored to the industry’s quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automotive sector’s ISO/TS 16949, where only firms with an active request for quotation, or on the bid ..
Overview Health care providers rely on a variety of tools to diagnose conditions and guide treatment decisions. Among the most common and widely used are in vitro diagnostics (IVDs), which are clinical tests that analyze samples taken from the human body. Patients may receive—or forgo—medical care based on diagnostic test results, making it critically important ..
THE ISO 10993 STANDARDS Technical Committee 194 meets annually in the spring to review progress made on the various 10993 standards and to chart a course for the coming year. Recent meetings were held in Stockholm in 1996 and in the UK city of York in 1997; the 1998 meeting will be held in the ..
GUDID contains ONLY the device identifier (DI) portion of the UDI, which serves as the key to obtain device information in the database. While GUDID does not include production identifiers (PIs), GUDID contains PI flags to indicate which PI attributes are in the UDI. Accessing Information of GUDID To access information of the GUDID, public ..
IEC 60601 is a series of technical standards for the safety and effectiveness of medical electrical equipment, published by the International Electrotechnical Commission. First published in 1977 and regularly updated and restructured, as of 2020 it consists of a general standard, about 10 collateral standards, and about 80 particular standards. Many companies view compliance ..
Evaluation and management coding (commonly known as E/M coding or E&M coding) is a medical coding process in support of medical billing. Practicing health care providers in the United States must use E/M coding to be reimbursed by Medicare, Medicaid programs, or private insurance for patient encounters. E/M coding is the process by which physician-patient ..
Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. The purpose of process validation is to ensure varied inputs lead ..
The international standard IEC 62304 software life cycle processes is a standard which specifies life cycle requirements for the development of medical software and software within medical devices. It is harmonized by the European Union (EU) and the United States (US), and therefore can be used as a benchmark to comply with regulatory requirements from ..
The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices. Medical devices that come into contact with the human body are required by the regulatory ..