Managing Risk in Medical Connectors
Fischer Connectors highlights important changes to risk management requirements enacted by the Food and Drug Administration (FDA) and the implications to manufacturers of medical devices.
Understanding these changes will allow manufacturers to adjust their business plans and adapt accordingly. Manufacturers now bear responsibility for conducting risk management processes in compliance with applicable standards. Fischer Connectors believes working with qualified suppliers will improve a manufacturer’s ability to comply with these new quality systems and help maintain a competitive edge.
Download this free whitepaper to find out more about the changes, which include new risk-based device classification, assessment requirements for premarket review, the emergence of risk management methodologies in regulation, and IEC 60601-1 technical standards.