The Importance of Nonconforming Product Control Control of nonconforming product is a fundamental quality management system requirement that directly affects product quality and patient safety. ISO 13485:2016 Clause 8.3 requires organizations to ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. For medical device manufacturers, the consequences…

Read More

The Case for Continuous Improvement Medical device quality management systems must do more than maintain minimum compliance with ISO 13485 and regulatory requirements. They must continuously improve to keep pace with evolving technology, regulatory expectations, customer needs, and competitive pressures. Organizations that achieve certification and then maintain the status quo eventually fall behind, as the industry and its requirements…

Read More

Why Auditor Selection Matters The value of an independent audit depends entirely on the competence, objectivity, and professionalism of the auditor conducting the assessment. Selecting the right independent auditor is therefore a critical decision that affects the quality of your quality oversight, the usefulness of audit findings, and the return on your audit investment. Not all independent auditors are…

Read More

The Importance of Post-Market Surveillance Post-market surveillance (PMS) is the systematic process of collecting, analyzing, and acting on information about medical device performance after the device has been placed on the market. Under both the FDA QMSR and the EU MDR, post-market surveillance is a mandatory component of the quality management system, and its effectiveness is increasingly scrutinized during…

Read More