SGS North America Blog

Under EU MDR, Post-Market Surveillance is no longer passive. Learn why PMS must now function as a continuous, data-driven system connected to risk, clinical evidence, CAPA, and technical documentation.

Learn why EU MDR clinical evaluations face increased scrutiny and what makes a CER stronger, clearer, and more defensible during certification body review.

OSHA’s proposal could limit General Duty Clause enforcement for hazards inherent to certain high-risk professions, potentially reshaping employer safety obligations and worker protections.

OSHA’s proposed Emergency Response Standard would modernize protections for responders by expanding coverage and strengthening training, hazard assessment, PPE, medical evaluation, and health-monitoring requirements

PHMSA’s new explosives rule streamlines classification and approvals, expanding self-certification options, digitizing submissions, and reducing regulatory burdens while maintaining safety standards and improving supply chain efficiency.

Learn how MDSAP goes beyond traditional audits by combining ISO 13485 with country-specific regulatory requirements in one deeper, more comprehensive audit process.

ISO 14971 risk management fails when risk files stop evolving. Learn why complaints, CAPA, and real-world evidence must continuously feed risk evaluation.

EU MDR readiness is not about having more documents. It is about proving traceability, connecting evidence, and demonstrating a clear regulatory story across the device lifecycle.

FDA QMSR is here. Learn what changed in 2026, what stayed the same, and why ISO 13485 certification alone may not be enough.

IVDR is no longer optional. Discover what’s changed, why compliance is tougher, and how to navigate new requirements without derailing your timelines.