Search results
Results from the WOW.Com Content Network
Standards for validation and verification of medical laboratories are outlined in the international standard ISO 15189, in addition to national and regional regulations. [1] As per United States federal regulations, the following analytical tests need to be done by a medical laboratory that introduces a new testing device:
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
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.
EN 868 Packaging materials and systems for medical devices to be sterilized, General requirements and test methods; ISO 11607 Packaging for terminally sterilized medical devices; Package testing is part of a quality management system including verification and validation. It is important to document and ensure that packages meet regulations and ...
As part of a risk management system, decisions on the extent of validation and data integrity controls should be based on a justified and documented risk assessment of the computerised system." The subsequent validation or verification of computer systems targets only the "GxP critical" requirements of computer systems. Evidence (e.g. screen ...
Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices.
For example, medical devices and products are often sterilized in the package. The sterility must be maintained throughout distribution to allow immediate use by physicians. A series of special packaging tests is used to measure the ability of the package to maintain sterility. Verification and validation protocols are rigidly maintained.
ISO 16140 Microbiology of the food chain – Method validation ISO 16140-1:2016 Part 1: Vocabulary; ISO 16140-2:2016 Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method; ISO 16142 Medical devices – Recognized essential principles of safety and performance of medical devices