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 ...

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 ...

A single swap, say a fluoropolymer gasket or filter, can force requalification, validation and refiling. Fluorine sits in a meaningful share of APIs, and fluoropolymers run through tubing, stoppers, ...

The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...

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 ...

On the surface, unique device identification (UDI) is a simple concept. Put the device identifier (DI) on the device label in machine‑readable form. Include the production identifiers (PI) that you ...