Design Verification and Validation of Class III Medical Devices Under 21 CFR 820: Challenges, Solutions, and Regulatory Compliance

Bhanu Prakash Mettu

Abstract: When developing Class III medical devices, companies must meet strict FDA standards (21 CFR 820) to thoroughly test and confirm the designs created. This article will look at the challenges and problems of following these rules for high-risk devices that usually keep people alive or treat severe health issues. These products need detailed risk studies, repeated safety checks for materials used in the body, and real-world testing to prove they work. Problems like poor record-keeping, weak patient data, or ignoring monitoring of products after launch can often result in delays or recalls. To fix this, I suggest using a bespoke created risk management plan, updating safety tests as designs change, and using developing tools to track every design step. A heart pump (VAD) example shows how these work in reality. The goal is to help meet FDA standards, keeping patients safe.

Keywords: FDA Class III devices, 21 CFR 820 compliance, design testing, safety checks, risk analysis, material safety, real-world device testing

How to Cite?: Bhanu Prakash Mettu, "Design Verification and Validation of Class III Medical Devices Under 21 CFR 820: Challenges, Solutions, and Regulatory Compliance", Volume 7 Issue 8, August 2018, International Journal of Science and Research (IJSR), Pages: 1714-1718, https://www.ijsr.net/getabstract.php?paperid=SR18809103504, DOI: https://dx.doi.org/10.21275/SR18809103504