What’s Killing Your Change Review Cycle Times?
Companies today face many challenges as they scale from early research and development stages to commercial production. Global competition, environmental compliance, and more distributed supply chains are just a few hurdles that must be overcome. The stakes are high if you fail to innovate and beat your competitors to market. To succeed, your new product development and introduction (NPDI) processes rely on fast and effective engineering change reviews. So, what ...
Feb. 19, 2019
Five Questions Every Medical Device Manufacturer Should Ask About QMS Solutions
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 a specific device, it does state that manufacturers “should use good judgment when developing their quality system and apply those ...
Feb. 11, 2019
How Medical Device Manufacturers Can Avoid Major Device Recall Factors
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 single-quarter recalls since 2005, clocking in at 360 recalls affecting 42.4 million devices.So, what gives? Why ...
Jan. 31, 2019
Keys for CAPA Success
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 and supporting medical devices in today’s highly regulated marketplace. While CAPA-related regulations do not specify every detail required ...
Jan. 22, 2019
Navigating the 510(k) Clearance and PMA Approval Process
Introduction There 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 the device is safe and effective” through methods like clinical trials, and results in FDA “approval ...
Jan. 7, 2019
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