Quality Systems Requirements:

"FDA compliance" often includes maintaining a quality system. Comprehensive quality management systems are required for all US companies involved with medical device design, manufacture, assembly, contract sterilization, installation, relabeling, remanufacturing, repacking, specification development, and initial distribution. The Federal Regulation 21 CFR Part 820 Quality System Regulation (QSR) defines the quality system requirements that apply to medical device manufacturers. The FDA is responsible for periodic inspection to verify QSR compliance of all medical device companies.

Separately, the International Organization for Standardization (ISO) has developed a quality management system standard for medical device companies, documented in ISO 13485. This international standard is optional for U.S. medical device companies that only sell domestically. However, ISO 13485 compliance is often a requirement for medical devices distributed internationally, including within Canada, Europe, and Australia. Compliance to ISO standards is certified through independent Notified Bodies and must be accomplished before placing the CE mark on a medical device.