Regulatory and
Compliance

Delivering Safe,
High-Quality Products

THE CHALLENGE:
Launching Products While Ensuring Compliance is Hard

With global competition and dispersed teams and partners, developing and delivering innovative products to your customers can be challenging. Ensuring safe, high-quality products are launched on time with ever-evolving regulations is even tougher.

Today’s global innovators must meet a myriad of environmental, safety, and federal compliance regulations to sell products to consumers.

Arena provides cloud-native product lifecycle management (PLM) and quality management system (QMS) solutions to address FDA, EU MDR, and ISO compliance directives, along with Export Controls and environmental regulations.

HOW WE HELP:
Connected regulatory compliance management

Arena helps high-tech electronics, medical device manufacturing, aerospace and defense, and many other industries meet continually evolving regulatory compliance requirements. Every item, assembly, and related process can be viewed to determine whether your products are designed for compliance.

Arena PLM and QMS solutions enable your quality and product teams to design and deliver compliant products fast.

Connected-regulatory-compliance-management

EXPLORE REGULATORY COMPLIANCE REQUIREMENTS

Arena simplifies compliance by connecting teams to work together and introduce new products on time and under budget. To learn more about how we support and streamline regulatory compliance, explore the following requirements.

Medical Device Compliance

FDA Title 21 CFR Part 820, Part 11, and Design Controls
Software validation services to simplify meeting FDA requirements

Environmental Regulation

Environmental compliance for RoHS, REACH, WEEE, and Conflict Minerals
Integrations to component databases like SiliconExpert and Octopart

Export
Controls

ITAR and EAR compliance requirements for product development elements
Flow-down requirements from top-tier prime contractors or up-channel suppliers

INDUSTRIES WE SERVE

If you make sophisticated products or work with dispersed teams and supply chains, learn how Arena addresses your key challenges.

INDUSTRIES

ARENA MAKES IT EASY TO DEMONSTRATE COMPLIANCE

ITAR and EAR compliance no longer requires organizations to adopt manual, paper-based processes or settle for limited and expensive on-premises PLM tools. To win in the competitive defense market, electronics defense companies need to embrace the power of new technologies in the Cloud.

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