Where MedTech professionals gain clarity and confidence to navigate complex risk, quality, and leadership challenges.
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QMSR QuickTake #48: Labeling Is More Than a Compliance Requirement
In responding to Comment #37 in the preamble of the QMSR1, FDA addresses a request to define labeling and marketing within the regulation.
FDA declined. “Label” and “labeling” are already defined in the FD&C Act, while marketing is not spe...
TAI #48: Can You Trace a Safety Characteristic From DFMEA to PFMEA?
Dear colleagues:
Design FMEA and Process FMEA are different analyses, usually performed by different teams for different purposes.
But they should not tell disconnected risk stories.
A design failure mode may be controlled by a specifica...
Executive Brief: PCCPs as a Competitive Strategy
PCCPs can turn regulatory cycle time into a competitive advantage, but only if the evidence needed to support future change is funded in advance.
Predetermined Change Control Plans (PCCP) are often discussed as a regulatory mechanism for m...
QMSR QuickTake #47: Preserving Product Through the Distribution Chain
In responding to Comment #36 in the preamble of the QMSR1, FDA addresses differences in how ISO 13485 and FDA regulations use the term distributor.
For QMSR purposes, FDA relies on the ISO 13485 framework and emphasizes that the quality ma...
TAI #47: When Supplier Audits Lose the Product Risk Context
Dear colleagues:
Most organizations would say their supplier audit program is risk-based.
And in many cases, it is.
Suppliers may be classified by criticality, performance history, previous audit findings, CAPAs, or other factors, and th...
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