regulatory compliance

The FDA is inviting medical device developers to participate in the READI-Home Innovation Challenge, seeking proposed solutions for home-use medical technologies that reduce hospital readmissions, with selected participants receiving direct regulatory feedback to refine their designs.

The FCC has cleared its first four drone systems from the Covered List after the Department of War determined they pose no national security risk. The move opens a conditional approval pathway for UAS manufacturers seeking U.S. import and sale authorization.

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.

Medical electrical equipment standards are complex—and noncompliance is costly. This article breaks down the top 10 barriers manufacturers face when navigating IEC 60601 and related standards, from EMC testing and isolation diagrams to risk management and software documentation, with practical guidance to streamline certification and avoid delays.

The IEC 60601 family of standards is undergoing its most significant update in decades. This article explains how the 4^th Edition of IEC 60601‑1 restructures safety, performance, terminology, and collateral requirements—and what these changes mean for medical electrical equipment development, conformity assessment, and future regulatory pathways.

Product documentation can protect manufacturers—or expose them to serious liability. This article explains best practices for managing product safety records across the product lifecycle, including defensive writing, document retention, post‑sale reporting, and structured document management programs that demonstrate proactive commitment to safety, regulatory compliance, and product liability risk reduction.

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.

By understanding the real-world applications and significance of EMI filters, engineers can design and implement effective solutions to manage electromagnetic interference across various industries, ensuring the smooth operation and compliance of electronic systems.

“One pound of learning requires ten pounds of common sense to apply it.” - Persian...