Kategoria: News

The 2025 revision keeps biological evaluation firmly inside ISO 14971 risk management and across the full device life cycle. Your…

ISO 10993-1:2025 embeds the biological evaluation within ISO 14971’s risk-management framework. The standard explicitly requires identifying biological hazards, estimating their…

Biocompatibility testing is essential for every medical device, ensuring safety, regulatory approval, and market success. The process, however, can be…

Biocompatibility testing is not just a regulatory requirement—it is a cornerstone of medical device safety, market approval, and long-term trust….

Wearable medical devices are transforming healthcare with continuous monitoring, real-time diagnostics, and improved patient engagement. However, their design introduces distinct…

Biocompatibility testing is a vital part of preclinical evaluation, but it’s just one piece of the larger puzzle. Manufacturers often…

Pre-submission is a critical phase in medical device development, especially under EU MDR. It’s the point where all your documentation…

In the fast-paced world of medical device innovation, biocompatibility is sometimes treated as an afterthought — a regulatory hurdle addressed…

In the realm of medical device development, ensuring biological safety is essential to protect patient health and to comply with…

A Biological Evaluation Report (BER) is a cornerstone document in the biological risk assessment process for medical devices. It integrates…