Design is a commonly outsourced process. As with all services, it requires significant quality considerations. The ability to implement a seamless and sound quality management system (QMS) for a ...

Medical device companies, listen up. There is zero excuse for not complying with medical device quality system regulations. FDA has published and makes available ALL regulations required for medical ...

CEOs should monitor customer feedback, especially complaints. Introducing a quality management system (QMS) helps address problems so they don’t recur. CEOs often resist implementing a QMS for their ...

Quality management system standards are a great tool for organizations wanting to plan an effective and efficient quality management system. ISO 13485, the ISO standard for medical device quality ...

Eradicating paper-based workflows and standalone solutions operating in isolation provides a good starting point to update quality management processes. As the saying goes, “the only constant in life ...