MDSAP Is A Snap If Your Firm Follows Quality Systems Standard ISO 13485, Auditor Says
NSF International's Brian Ludovico explains why device-makers that already follow international quality systems standard ISO 13485 shouldn't be nervous about taking part in the Medical Device Single Audit Program. Ludovico also shares MDSAP participation numbers and says firms should feel at ease knowing that the program's auditing organizations undergo a rigorous process to become recognized by the MDSAP Regulatory Authority Council.
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Q&A: New Details Emerge From FDA About Long-Delayed Draft Rule That Harmonizes Quality System Reg With ISO 13485
Melissa Torres, a US FDA official who is one of many working on the agency’s revision of the Quality System Regulation, offered a few nuggets of news about the process on 8 June. Among them: device makers will have “a few years” to comply with the new QSR; the Quality System Inspection Technique (QSIT) will change; investigators and device center staff will undergo training; and more.
A Softer, Gentler FDA Inspectorate? It’s Possible With QSR/ISO 13485 Harmonization, Auditing Expert Says
Let’s be blunt: Device-makers aren’t particularly fond of facility inspections by the US FDA. From audits that can sometimes drag on for weeks to nightmarish inspections well-documented by industry experts, there’s no shortage of tales of investigators that were difficult to handle. But the agency’s ongoing rewrite of its Quality System Regulation to harmonize it with international standard ISO 13485 could “soften FDA’s inspectorate,” NSF International’s Brian Ludovico says. Also: How might the FDA’s Quality System Inspection Technique (QSIT) change, post-harmonization?
FDA's Quality System Regulation Is Mapped To International Standard ISO 13485 – And Vice Versa – In New Report From AAMI
A new Technical Information Report (TIR) from the Association for the Advancement of Medical Instrumentation compares regulatory requirements found in the US FDA's QSR to those in quality systems standard ISO 13485:2016. While the 146-page document is aimed at US device-makers, it could also be helpful to the FDA as the agency works to harmonize its QSR with the ISO standard.