Cloud QMS Simplifies Validation
Why the need to validate?In the journey to deliver safe and effective devices to market, medical device manufacturers must simultaneously manage a myriad of regulations. To maintain quality compliance throughout the manufacturing process, quality leaders have the option to use various types of quality management systems (QMS). They can leverage manual, paper-based ones; on-premises software; or cloud-based QMS software. The FDA doesn’t regulate what type of system manufacturers ...
March 13, 2019
FDA Audits: The True Cost of Quality Problems
IntroductionFDA audits are an unavoidable and often unwelcome reality for medical device manufacturers, and knowing how to prepare for them effectively and confidently is vital to success. Not having a proper plan in place can have dire consequences for organizations. Quality failures can result in everything from warning letters to major compliance actions requiring facility shutdowns, and, since medical device recalls have been on the rise, the threat of regulatory ...
Feb. 28, 2019
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
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