Arena Blog

Topic: Medical Device

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 Training Quizzes Prove Your Teams Know What They’re Doing

Arena Training Management is a cloud-based solution embedded in our product realization platform that ensures regulatory and corporate compliance, increases effectiveness for training programs, and streamlines training processes. It helps you create and manage your employee and partner training plans, with a single secure system connected to your product and quality processes. 

Nov. 8, 2017

The Surprising Secret Why Top Medical Device Companies Succeed

Choosing the right component part at the right time is one of the most important aspects of medical device product design. Unfortunately, many medical device or high tech companies don’t utilize a standardized method for selecting electronic parts. A component database, when integrated with a product development platform, is the only realistic way medical device companies can comply with ever-changing compliance mandates and frequent adds to both the REACH and RoHS hit lists.

Oct. 18, 2017