3 Key Challenges Facing Medical Device Quality Leaders
Medical Device Quality PressuresQuality leaders face a lot of pressure in their role in delivering safe, high-quality products to market. In the medical device industry, that weight is even greater as the quality of their products can have a direct and dramatic impact on a person’s health. Successfully navigating a sea of FDA, ISO, and other regulatory requirements is a primary source of this pressure to deliver medical devices ...
Nov. 8, 2018
Why Today’s Medical Device Teams Need a Product-Centric Approach
IntroductionGetting quality and product teams on the same page remains a key challenge for medical device manufacturers. The development of innovative medical devices demands consistent communication across teams to comply with FDA regulations, and each stakeholder group across new product development and introduction (NPDI) plays a crucial role in bringing a safe and compliant medical device to market.For FDA regulated companies, establishing and following quality systems is a must ...
Oct. 26, 2018
Arena Welcomes Omnify
Arena Solutions is excited to announce the acquisition of Omnify Software. After more than a decade competing against each other, Arena and Omnify have joined forces to better serve product companies in high tech electronics, medical device, and other markets. Complex product companies today have a greater need to integrate more electrical, software, and sensors to meet growing customer demand for connected devices and solutions. Arena and Omnify have been ...
Oct. 24, 2018
Eliminate Barriers to Innovation Part I
Complex Products and Regulatory Compliance ChallengesOver the last few years, consumer electronics companies have quickened the pace of innovation to provide customers with better products. Distributed teams and global supply chains are the norm. Everyone is racing to leverage the Internet of Things (IoT) to connect people, data, and devices in a variety of settings. And, if more complex products and supply chains weren’t enough, ever-increasing environmental, safety, and ...
Oct. 15, 2018
Parallel Prototyping to Optimize Process Designs
Have you ever been part of poorly run projects? Experienced analysis paralysis? Been frustrated by costly overruns or implementation delays? If so, consider how parallel prototyping can help you harness the power of all team members to create more optimal processes, while avoiding the pitfalls associated with large teams trying to reach consensus.I was recently involved in a project team meeting, one of the best of my career, as ...
Sept. 26, 2018
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