Regulators now separate fluoropolymers from other PFAS, but lifecycle risks remain. Readiness starts with knowing which uses, reporting duties, and exposures matter most.

Discover why micro molding requires a complete manufacturing architecture integrating design, tooling, automation, metrology, ...

Clean audit results confirm past compliance but say little about future performance. As products, markets, and regulations ...

Quality teams already use general-purpose AI for deviations and submission drafts without validation. Regulators expect ...

Passing inspections no longer signals that a growth-stage biotech can sustain clinical-stage complexity. The gap between ...

Spreadsheets and siloed quality systems conceal five compounding exposures, from single-person knowledge dependencies to ...

Source: Secant Group & Polyzen, part of the Solesis family of companies Solesis brings together the specialized strengths of Secant Group, Polyzen, and Charter Medical to help innovators move from ...

Regulatory oversight and scrutiny of health technology (healthtech) companies has emerged as a priority for the federal government. Charged with mitigating fraud and abuse, protecting consumers, and ...

In 2023, the FDA made the electronic Submission Template And Resource (eSTAR) mandatory for most 510(k) submissions. Although eSTAR is not an AI tool, the move was the first definitive leap toward the ...

Product labels that appear on device packages, admittedly, are not the most exciting part of medical device product design and development. They lack the excitement of scientific discovery, the cachet ...

An FDA warning letter is more than a formal notice; it’s a visible sign that a company’s quality system has failed to meet critical expectations. Yet behind every warning letter lies a wealth of ...

European Medical Device regulations define “benefit-risk determination” as "the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose ...