IntroductionTo help ensure that medical devices are safe for use and will function as intended, the FDA requires that manufacturers of these products establish and follow quality systems in accordance with current good manufacturing practices (CGMP). While the quality system regulation (QSR) does not prescribe how a manufacturer must produce […]

Introduction2018 was a difficult year for many medical device manufacturers, with large spikes in Class I recalls and a whopping 186,580,917 devices across 343 recalls affected in Q1. While the impact in Q2 and Q3 was lower, the number of recalls was still high. In fact, Q2 had the most […]

IntroductionEstablishing Current Good Manufacturing Practices (CGMPs) ensures that medical device manufacturers can better comply with regulations and standards like FDA 21 CFR part 820.100 and ISO 13485, including quality systems that identify, analyze, and correct quality issues. These corrective and preventive action (CAPA) processes are a major component of delivering […]

IntroductionThere are two main paths that medical device manufacturers can use to bring moderate- and high-risk devices to market with the FDA’s permission: through submittal of a premarket approval (PMA) request or 510(k) application.Submitting a PMA application is a more extensive approach, requiring substantial evidence that provides “reasonable assurance that […]

IntroductionAs globalization of medical device supply chains has continued to increase, regulatory bodies have grappled with how to bridge the gap between domestic and foreign regulation. Without a unified approach to both, the daily practice of ensuring that regulatory processes are followed and properly documented is even more challenging. The […]

IntroductionMaintaining readiness for FDA inspections can be arduous and time-consuming, and the need for preparedness is growing. While the FDA continues to issue more observations than Form 483s, the number of observations has been decreasing, while the count of Form 483s has been increasing. A renewed focus on the quality […]

Connecting Products and Projects Helps Streamline Regulatory ComplianceThis is the fourth and final part of our series on how to break down the barriers to product innovation. We have demonstrated how to connect disparate product teams with a single source of truth to simplify collaboration, streamline new development, and keep […]

Meeting Product Requirements and Streamlining Engineering Changes Throughout this series, we have been exploring how manufacturers can streamline new product development and new product introduction (NPDI) by connecting the entire new product team with a centralized product record for a single source of truth. During the first installment, we covered […]