product safety

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.

Warnings and instructions are a necessary part of any safe product. Rarely is a design so safe that there are no warnings and instructions that need to be followed. On the other hand, failure to follow warnings and instructions can turn an otherwise safe product into one that is hazardous. Is it foreseeable that users will not read or follow this information? And if so, what effect does that have on the manufacturer’s potential legal liability for injuries suffered while using this product?

Legal problems arise as a result of most recalls. These can take the form of regulatory problems, product liability lawsuits, retailer problems, and damage to a company’s brand reputation. Well before undertaking a recall, product sellers need to consider what problems might occur and what they need to do to minimize them.

Circuit spacing is a key element in minimizing electrical shock and fire risks, which is critical for safe product development. This publication provides simplified guidelines to help understand, navigate, interpret, and apply circuit spacings, contributing to a successful safety and certification experience.

Foreign manufacturers sometimes intentionally or unintentionally cut corners on safety and quality because they are less likely to be held liable in the U.S. for problems created by their products. U.S. manufacturers who buy from foreign companies must alter their relationships with such manufacturers to account for this possibility and enhance the safety of their products to protect themselves better if problems do occur.