<h2 id="introduction">Introduction</h2> <p>Biocompatibility testing plays a crucial role in ensuring the safety and efficacy of medical devices. Governed by a complex regulatory framework, including s...
<h2 id="introduction">Introduction</h2> <p>Biocompatibility testing plays a crucial role in ensuring the safety and efficacy of medical devices. Governed by a complex regulatory framework, including standards set by entities like the FDA and ISO, these tests evaluate how devices interact with the human body and identify any potential adverse effects. Adhering to these standards is not only about compliance but also about fostering innovation and ensuring the availability of safe and effective medical technologies.</p> <p>This article explores the regulatory landscape, FDA guidance, ISO standards, material selection, key concepts in biocompatibility testing, the role of accreditation, best practices, and common challenges in conducting these tests. By understanding and navigating this complex environment, medical device manufacturers can protect patient health and bring forward innovative technologies.</p> <h2 id="regulatory-framewo…