PFAS exposure for device manufacturers no longer hinges on a single rule or a single material. FDA has drawn a firmer line around fluoropolymers, yet state reporting requirements, a still-evolving EU ...
Regulatory exemptions for essential PFAS uses in pharmaceuticals can create a false sense of security. Reporting duties, wastewater and solid waste obligations, CERCLA liability, and a major ...
Clean audit results confirm past compliance but say little about future performance. As products, markets, and regulations ...
Spreadsheets and siloed quality systems conceal five compounding exposures, from single-person knowledge dependencies to ...
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 ...
From Concept To Commercialization: How Solesis Integrates Biomaterials Into Your Healthcare Solution
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 ...
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 ...
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