Topic: QMS
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
Connecting Distributed Teams in an Era of Accelerating Innovation
Ray Kurzweil—best-selling author, entrepreneur, futurist, inventor, and currently Director of Engineering at Google—famously made the point that technology is advancing more quickly than ever before. For example, the number of transistors on a semiconductor has been doubling about every two years for the past four decades in accordance with Moore’s Law. And, as Kurzweil points out in in his 2005 book The Singularity is Near*, DNA sequencing ...
June 26, 2018
What Kind of Quality Management System Do You Need?
Donuts. Bowling balls. Tires. What do these things have in common? They’re all round and they all have holes. Sometimes holes serve a purpose. But when it comes to software, holes—or gaps—are not good.
March 16, 2018
Two Audits in One Day? Yawn. No Problem.
How Arena gave Apical Instruments so much confidence that having two audits in the same day actually saved them time and money.
June 28, 2017
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