product safety

Compliance testing labs are where products prove they're ready for the real world — but what actually happens inside one? This primer walks through the key steps, tools, and methodologies engineers use to evaluate safety, performance, and regulatory adherence before products reach market.

The FDA has finalized its guidance on human factors information required in medical device marketing submissions, outlining a risk-based framework for 510(k)s, PMAs, De Novo requests, and HDE applications. Here's what manufacturers need to know before their next premarket submission.

The FDA has updated its list of more than 1,700 recognized voluntary consensus standards used to demonstrate compliance in medical device premarket submissions. Find out which specialties are covered and how declarations of conformity can streamline your path to market authorization.

The EU Commission is seeking public comment on draft guidelines designed to help providers and deployers determine whether their AI system qualifies as high-risk under the AI Act — with the comment period open through June 23, 2026.

This whitepaper demystifies the IEC 60601 family of medical electrical safety standards, explaining general, collateral, and particular requirements and how they impact global market access. It offers practical guidance on integrating compliance, risk management, and testing strategies early to streamline regulatory approval and accelerate time to market.

The biggest compliance risks to your product launch are quiet, early, and easy to miss. Learn how to integrate product safety compliance from day one — and why the engineers who do build better products and reach market faster.

The FDA has finalized guidance on premarket submission requirements for weight loss medical devices, covering non-clinical testing, clinical study design, and benefit-risk analysis. Developers of intragastric implants, aspiration therapy systems, and neuromodulators will want to review the agency's recommendations closely.

Global markets don’t run on assumptions—they run on accredited data. ISO/IEC 17025 laboratory accreditation gives manufacturers the consistency, accuracy, and credibility regulators expect. See why accreditation has become a competitive advantage across every major industry.

Compliance failures can devastate product development—leading to recalls, financial losses, and long-term brand damage. This article explores real-world engineering case studies, including Samsung’s battery recall, Volkswagen’s emissions scandal, Intel’s processor bug, and Boeing’s 737 MAX issues, revealing actionable lessons to strengthen compliance, safety, and quality processes across industries.

The EU Commission is seeking public input on modernizing its product safety framework through two key initiatives: simplifying market access rules, CE marking, and conformity assessments while reducing administrative burdens, and strengthening market surveillance to help authorities better enforce compliance and prevent unsafe products from reaching consumers.