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19 results found

MDSAP: How It Differs from Traditional Audits
Learn how MDSAP goes beyond traditional audits by combining ISO 13485 with country-specific regulatory requirements in one deeper, more comprehensive audit process.
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ISO 14971 Risk Management: Where Companies Fail
ISO 14971 risk management fails when risk files stop evolving. Learn why complaints, CAPA, and real-world evidence must continuously feed risk evaluation.
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EU MDR Readiness: Why Companies Still Struggle
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.
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ISO 13485 vs U.S. FDA Quality Management System Regulation (QMSR)
FDA QMSR is here. Learn what changed in 2026, what stayed the same, and why ISO 13485 certification alone may not be enough.
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IVDR Compliance in 2026: What Has Changed and What You Should Do Next
IVDR is no longer optional. Discover what’s changed, why compliance is tougher, and how to navigate new requirements without derailing your timelines.
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SGS and CertX Expand Digital Trust Services for AI and Autonomous Systems
SGS and CertX are expanding DIGITAL TRUST services to help safety-driven industries assess, inspect, and certify AI-powered and autonomous systems with greater confidence and compliance.
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Preparing for EUDAMED: A Guide for Legal Manufacturers
Get ready for EUDAMED’s 2026 mandate. Learn how legal manufacturers can prepare with practical steps for data accuracy, compliance, and smooth integration into the EU’s medical device regulatory system.
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Food Safety Matters More Than Ever: How SGS Ensures Quality and Protection
Learn how SGS protects public health with advanced food testing and expert analysis, recently featured on NBC Nightly News for its vital role in ensuring food safety, quality, and regulatory compliance.
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Questions to Ask When Selecting Your Food Safety Consultant
Ensure food safety and compliance by choosing the right consultant. Ask these ten key questions to assess expertise, experience, and effectiveness in protecting your brand and consumers.
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Nucleus Biologics Achieves EXCiPACT Certification for GMP Quality Cell Culture Media
Nucleus Biologics achieves EXCiPACT certification, becoming the first custom cell culture media company to meet Excipient GMP standards—ensuring quality, safety, and scalability for cell and gene therapy innovators.
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