FDA The Food and Drug Administration (FDA) has published detailed guidance dedicated to the use of International Standard ISO 10993-1 “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”. International...
Uncategorized ISO, the International Organization for Standardization, issued a new standard dedicated to the application of risk management to medical devices. Brief Overview of ISO standards ISO is an organization comprised of several national standards bodies. The...
Uncategorized What Is It? ISO 13485 is a quality management system that is used internationally. It controls safety in work environments, risk management, and design, and creates requirements for inspections, documents, procedures, and verification of safety and effectiveness of...
North America The FDA will shift from QSR to ISO 13485 so that their system regulations can harmonize with international practices to reduce confusion and and lessen the burden for medical device manufacturers. What is QSR Quality System Regulation (QSR), also known...
Africa Although medical device companies are not required to comply with ISO 13485:2016 until March of next year, the International Organization for Standardization (ISO) Technical Management Board is contemplating rewriting the quality systems standard. The group that...
