Regulatory Compliance

The U.S. Food and Drug Administration (FDA) conducts routine and for-cause inspections to ensure medical device manufacturers comply with regulatory requirements, including those related to Reports of Corrections and Removals. Understanding the objectives of these inspections and taking proactive steps to prepare can help manufacturers maintain compliance and avoid potential enforcement actions. Key Objectives of […]

The FDA plays a pivotal role in ensuring that medical devices in the market are safe and effective. One crucial aspect of their oversight is inspecting manufacturers’ compliance with Medical Device Reporting (MDR) requirements. For companies, understanding the key objectives of these inspections and preparing adequately can streamline the process and avoid compliance issues. Key Objectives of

In the realm of medical device manufacturing, ensuring compliance with FDA regulations is essential. One of the core areas of focus during FDA inspections is the Production and Process Controls (P&PC) subsystem. This critical component ensures that devices meet their specifications consistently. Below, we explore the main objectives of an FDA inspection of the P&PC

For medical device manufacturers, ensuring compliance with the FDA’s Quality System Regulation (QSR) is critical. A key area of focus during FDA inspections is the Corrective and Preventive Action (CAPA) subsystem, which is vital for addressing and preventing quality issues. Let’s explore the main objectives of an FDA inspection of the CAPA subsystem and practical steps to

Medical device manufacturers are no strangers to FDA inspections. The Management Controls subsystem is a cornerstone of these evaluations, focusing on how effectively a company’s management ensures quality in device design, manufacturing, and distribution. Preparing for an FDA inspection can be unnerving, but understanding the objectives of the Management Controls inspection and implementing proactive measures

The Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and effectiveness of medical devices. Through inspections guided by the Quality System Regulation (QSR) and Guide To Inspections of Quality Systems (QSIT Manual), the FDA assesses manufacturers’ compliance with quality standards. These inspections focus on ensuring that devices meet design, production,