Medical Device Quality Assurance and Regulatory Compliance

CRC Press

\""Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements.\"" > \""Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements.\"" > Background of standards and regulations: quality assurance and regulatory compliance; the FDA; the European Union; the global harmonization task force; software as a special case. Quality systems: the ISO 9000 series of standards; ISO 9000 requirements/ compliance; the ISO 14000 standard; ISO 14000 requirements/compliance. Quality devices: the EN46001 standard; EN46001 requirements/compliance; the ISO 13485 standard; ISO 13485 requirements/ compliance; IEC 601-1-4; IE.