Arena for the Medical Device Industry
Developing innovative, high-quality products in the medical device industry requires effective design and document controls that adhere to regulatory requirements, such as the FDA’s current Good Manufacturing Practice (cGMP) and 21 CFR Part 11. Arena provides a centralized device master record (DMR), design history file (DHF), and bills of material (BOMs) which are accessible globally to authorized users through ultra-secure, financial-grade design control workspaces.
Learn how Arena allows your company to revision control all files, design records, and standard operating procedures (SOPs) through change orders (ECOs) with electronic signatures on a validated system.
Related Medical Device Resources
Learn how Arena can help medical device companies better manage their device master records (DMRs), design history files (DHFs) and achieve medical device compliance on our Medical Device Compliance page.
Additional Resources
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