ITAR and EAR Compliance and Modern Product Development (Part I)
As a high tech electronics manufacturer, you have your hands full developing and producing today’s complex products—a mix of sophisticated electrical, mechanical, and software elements. If you participate in the defense market, you may also be subject to strict federal regulations governing at least some of your product data and processes—either directly as an ITAR- or EAR-registered company or from your customers as part of flow-down requirements ...
April 22, 2019
Robotics and Spreadsheets: A Dangerous Combination
As it turns out, replacing humans is no simple task—just ask anyone in the robotics field. Robots designed to do relatively simple tasks like taking inventory in a supermarket are incredibly complex, involving thousands or tens of thousands of electrical and mechanical parts, as well as software components. In addition to complexity and volume, many parts for robots rely on custom designs that cannot be sourced as off-the-shelf parts ...
April 10, 2019
Why Quality Teams Should Get Connected with Product Development
IntroductionQuality teams often think of their role as different and separate from product development. However, in today’s increasingly complex medical device market, a product-centric approach to quality management is fundamental to delivering high-quality devices.Next-level proactive quality management processes requires a closer connection between product development and quality teams to address potential quality issues and develop compliant processes. This connection improves collaboration, while fostering a smooth and innovative product ...
March 25, 2019
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
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