Partner Dennis Gucciardo discusses with Medtech Insight the four steps device makers can take to be in line with the US Food and Drug Administration’s (FDA’s) proposed Quality Management System Regulation (QMSR) once finalized. On a recent webinar addressing the QMSR hosted by the firm, Dennis said that device makers should be considering making changes to supplier quality agreements and updating procedures and records to incorporate ISO 13485 terminology, noting that FDA inspections will not magically become easier. He also shared that manufacturers should conduct a gap assessment to “identify what process procedure enhancements are required…Not just looking at things where process requirements are needed, but is there a need for record remediation?”
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