Risk and regulation management can often have an adverse impact on time to market and the cost of manufacturing medical device products. Today, manufacturers have to meet, manage and maintain increasingly rigorous compliance standards while, at the same time, balance increasing commercial pressures.
ISO 13485 is a globally recognised medical device standard and specifies requirements for a quality management system in order to ensure and verify that customer and regulatory conditions are met by the medical device industry. Compliance with ISO 13485 can enable medical device companies to implement and streamline robust processes and procedures to ensure quality, reliability and safety are achieved throughout the product lifecycle.
Within a shifting global market, consistently delivering high quality products or services can create competitive advantage for medical device companies. A robust product lifecycle that follows the principles of ISO 13485 can accelerate time to market and mitigate future risk for organisations.
This paper examines how the quality management product, Q-Pulse, matches up against specific ISO 13485 clauses in order to create a holistic and streamlined approach to quality management to achieve continuous improvement and competitive advantage.