Posts tagged with “Proposed 820.1 – Scope”

Quality Management System Regulation (QMSR) Alignment with ISO 13485:2016

Many organizations have struggled to comply with ISO 13485 and FDA regulations because the FDA did not formally recognize the ISO 13485 standard in their regulations. Now, the FDA is taking a step forward to incorporate ISO 13485 into their Part 820. This will potentially reduce the confusion manufacturers have experienced in the past. The […]