Micro Power Electronics, Inc. announced that it earned IS0 13485:2003 certification – a stringent, globally-recognized standard of quality management for medical device manufacturers. The company continues to maintain its ISO 9001 certification, an internationally recognized standard for quality management systems. The company believes that achieving ISO 13485:2003 certification gives it a unique competitive edge to improve time-to-market for new products while ultimately improving product quality for its current and prospective clients.
"The ISO 13485 certification demonstrates that Micro Power has built a systematic framework in which we monitor, measure and analyze our critical processes and feedback for our medical device manufacturer customers," said Greg Love, President and CEO for Micro Power. "Given our global customer base, ISO 13485 certification may become a mandatory requirement for medical contract manufacturers. Achieving this certification gives us a competitive edge and complements our current FDA registration."
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.