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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...
North America
This week, the FDA’s Center for Devices and Radiological Health (CDRH) announced its plans to create new regulations that would blend together two leading approaches to auditing medical device quality management systems, 21 CFR Part 820 and ISO 13485. According to the...
Consultant Post
by George C., Consultant on RegDesk As a result of fraudulent medical devices entering the US market (such as orgone accumulators and other quack medical devices), an increase in the number of medical device recalls, and various medical devices causing death and/or...
