Medical Device Insights

January 6, 2026 – Is a reported failure truly ‘user error’ or a symptom of a design interface deviation? This technical resource examines the boundary between Abnormal Use and Foreseeable Misuse under IEC 62366, providing a framework for analyzing the Design History File in litigation.

December 4, 2025 – In the analysis of medical device performance and regulatory adherence, the terms “Verification” and “Validation” (often abbreviated as V&V) are frequently conflated. However, under FDA Quality System Regulations (21 CFR Part 820) and ISO 13485, these represent distinct phases of the design control process with unique objectives and evidentiary requirements. A clear understanding of this dichotomy is essential for evaluating the completeness of a Design History File (DHF) and assessing adherence to regulatory frameworks. Misinterpreting these stages can lead to confusion regarding whether a device was tested against its engineering specifications or against the actual needs of the user.

October 13, 2025 – In the lifecycle of orthopedic implants, a significant technical paradox often emerges: a device can meet every applicable consensus standard during laboratory testing yet exhibit unexpected failure modes in the clinical environment. This discrepancy is particularly evident in the history of large-diameter Metal-on-Metal (MoM) hip systems. Understanding this gap requires analyzing the difference between Standardized Verification (testing to a code) and Comprehensive Validation (testing for the patient environment).

September 2, 2025 – In medical device litigation and regulatory enforcement, a “biocompatibility failure” is often framed as a static design flaw. However, engineering analysis frequently reveals that the root cause is not the base polymer, but rather dynamic variables within the supply chain and manufacturing process.

For attorneys and quality engineers, understanding the distinction between a “virgin” raw material and a processed, sterilized finished device is critical. A device may pass mechanical specifications yet fail ISO 10993 biological endpoints due to microscopic chemical alterations introduced during the manufacturing process or sterilization. This technical resource outlines the mechanisms behind these “unexpected” deviations.

May 26, 2025 – The 510(k) Premarket Notification is the regulatory pathway for the vast majority of Class II medical devices entering the US market. A frequent point of confusion in both engineering reviews and legal discovery is the distinction between a device being “identical” to a predecessor and being “substantially equivalent” (SE).

It is a common misconception that a new device must replicate the materials and design of its predecessor to achieve clearance. In reality, the regulatory framework anticipates and permits technological evolution. Understanding the engineering logic behind Substantial Equivalence is necessary for evaluating whether a device’s performance testing was sufficient to bridge the gap between an established “predicate” device and a new market entrant.