Insights from Christopher Hill, Director of Regulatory and Quality Affairs, Organ Recovery Systems This blog is the final of our three-part series on design controls. The first explained why “Good Design Controls Are Critical to Avoid FDA Issues” and the second entailed Vis Ayer’s account of “How Nevro Achieved Design […]

Highlights from our discussion with Vis Ayer, Senior Director of Quality at Nevro In our last blog, we explored why Good Design Controls Are Critical to Avoid FDA Issues. In this second part of our series, Vis Ayer of Nevro shares his experiences on the importance of good design controls. […]

We recently sat down with a few medical device companies to discuss how they deal with FDA requirements around design controls. We will share their experiences in this three-part series, but first want to lay the foundation for the design control discussion. Medical device companies recognize that having an emphasis […]

Software vendors have always sought to provide highly adaptable solutions by allowing customization. Most vendors will claim that it’s easy to customize their solution. However, there are two different approaches. One approach involves the need to program or code (customization) and the other involves using a simple user interface that […]

There are many nimble, cloud-based tools on the market today. I love using Microsoft Teams to collaborate with anyone in my company instantly and Trello to manage marketing deliverables and projects. A variety of similar collaboration tools, including Asana and Slack, have also emerged to help teams interact and share […]

Jeremy Timothy of Listen Technologies recently shared his experiences with Arena’s Scott Reedy during a webinar panel discussion focused on accelerating new product development. We wanted to share some of his noteworthy insights with our readers. Jeremy spent the last eight years as a Configuration Analyst and worked closely with […]

Sonos’ Julie Toscano recently sat down with Arena’s Scott Reedy to discuss best practices and share insights on how product lifecycle management (PLM) drives product development success. Julie has more than 20 years of electronic design and new product introduction (NPI) experience and over five years of PLM experience. Julie […]

We were pleased to have eMagin’s Director of Quality Assurance, Christine Pompa, share her experiences, challenges, and opportunities managing quality and continuous improvement with Arena’s Scott Reedy, Senior Director of Marketing at Arena. Christine and her team at eMagin moved to an automated system for product lifecycle management (PLM) to […]