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Introduction
Published in Marie B. Teixeira, Design Controls for the Medical Device Industry, 2019
In the United States, the quality system requirements for FDA-regulated devices are codified under 21 CFR Part 820—Quality System Regulation (QSR). Likewise, ISO 13485 is an international quality management system standard applicable to medical devices. ISO 13485 is considered compatible with the QSR. The QSR and ISO 13485 Standard include the requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing finished medical devices. Manufacturers are expected to adopt current and effective methods and procedures to control the design and development of medical devices.
Getting Started
Published in Ilkka Juuso, Developing an ISO 13485–Certified Quality Management System, 2022
ISO 13485 quality management is based on an international standard for quality management systems at medical device organizations and, more specifically, the ISO 13485 standard on “Medical devices. Quality management systems. Requirements for regulatory purposes”. The standard, and a QMS based on it, offers a way of defining, performing, and recording the operations of an organization engaged in medical device business. The quality management system set up by the organization provides a framework for these tasks and incorporates a notion of continuous improvement via a process of analyzing past performance and making appropriate improvements based on the analysis.
Biological Indicators for Sterilization
Published in James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, Handbook of Validation in Pharmaceutical Processes, 2021
Kurt McCauley, Nicole Robichaud, Karlin Gardner, Crystal Hostler
A number of standards exist that offer guidance for BI manufacturers (Table 12.3). ISO 13485 provides guidance for the quality management systems for medical devices. The ISO 11138 series, United States Pharmacopeia (USP), and European Pharmacopoeia (EP) provide details specifically for BI manufacturing controls and performance criteria. Compliance with these standards by the manufacturers is not mandatory; however, in complying, the BI user gains a level of confidence in the quality of the product.
Medical textiles
Published in Textile Progress, 2020
For determining conformance of medical devices to national and international regulations, products and devices may be tested to establish how well they perform under controlled conditions in the laboratory against a series of standards governed by the International Standards Organization, namely ISO 13485. ISO 13485 is a stand-alone quality management standard to regulate medical device manufacturing environments. There are also separate standards for technical specifications that can be used including British Standards, ASTM International, Standards Australia and Japan Medical Device and Pharmaceutical Regulations.