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

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 ...

For years, manufacturers relied on a table-based approach to determine allowable ethylene oxide residual limits, an approach that didn't adequately account for vulnerable patient populations or device ...

We know that getting a medical device to market from ideation to market launch is a project requiring tremendous skill, knowledge, time, money, and, often, some luck. When focus is on the road to ...

In micro manufacturing, successfully molding a part is only one piece of the challenge. When components feature extremely small dimensions and tight tolerances, the entire production system must be ...

The European Commission published COM(2025) 1023 on December 16, 2025. Since then, the commentary has been remarkably consistent: classification rules are relaxed for certain devices, fixed five-year ...