Medical device manufacturers and their supply chains must get their products to market quickly while facing new technological challenges, global competition, and the need to mitigate risks. Medical devices with electrical, mechanical, and software components introduce even more obstacles as companies strive to navigate the ever-evolving regulatory landscape including FDA (e.g., FDA 21 CFR Part 11 and Part 820), ISO (e.g., 13485, 14791), UL, OSHA, and environmental compliance (e.g., RoHS, REACH, conflict minerals) initiatives.

So how do medical device manufacturers address regulatory compliance?

Read this white paper to learn the best way to navigate compliance from early concept phases through commercialization with a single system of truth for all product and quality information available to internal teams and partners.

In this white paper, you will learn more about...

Improved Compliance

Continuous Improvement

Better Collaboration

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Helping You Innovate to Change the World

Thermo Fisher
Bio Rad

About Arena

Arena Solutions helps innovative electronic high tech and medical device companies create products that change the world. Arena unifies product lifecycle (PLM) and quality management (QMS) processes, allowing every participant throughout the product realization process from design to manufacturing to work together. With Arena, teams accelerate product development and delivery to increase profits. For more information, visit

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