Medical Device
Regulatory
Compliance

Simplify FDA and ISO Compliance

EXPEDITE READINESS FOR REGULATIONS AND REQUIREMENTS

Medical Device Compliance Safety

To ensure patient safety, medical device manufacturers must establish and maintain quality systems to meet regulatory compliance requirements specified by the FDA, ISO, and other regulatory bodies. Adhering to regulations like the FDA’s 21 CFR part 820 and ISO 13485 are key to your commercialization success.

Arena’s cloud-based QMS software helps you achieve and maintain strong design controls. This simplifies the management of standard operating procedures (SOPs), device history files (DHFs), device master records (DMRs), training records, and the entire product record by linking all quality and product information throughout new product development and introduction.

CLOUD QMS SIMPLIFIES REGULATORY COMPLIANCE

Introducing a safe, compliant, and innovative medical device to market is no easy feat. In fact, it requires orchestration between your quality, engineering, and operations teams, along with your supply chain partners. Arena Quality Management System (QMS) software provides you with a single system of truth to develop and introduce devices, while eliminating compliance risks.

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QUALITY
ASSURANCE

teams follow closed-loop quality processes to improve traceability

Regulatory Affairs icon

REGULATORY
AFFAIRS

establishes strong design controls and ensures regulatory compliance

Executive Teams icon

MANAGEMENT
TEAMS

improve adherence to training records, SOPs, and more

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ENGINEERING
TEAMS

gain visibility to continually improve compliant designs 

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DOCUMENT
CONTROL

can confidently prepare for and pass internal, ISO, or FDA audits

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EXECUTIVE MANAGEMENT

teams can make better decisions to speed commercialization

CONNECTED QUALITY PROCESSES

In a regulated environment, the key to introducing new products while maintaining compliance is connecting your product and quality records. Arena Solutions’ cloud QMS software provides a product-centric approach that links quality, training, supplier, and audit records to the entire bill of materials (BOM).

OPTIMIZES CLOSED-LOOP
QUALITY PROCESSES

  • Provides easy access and traceability to all teams to streamline the investigation of issues and speed resolution
  • Links quality and CAPA processes to product record to identify, analyze, and resolve issues quickly

REDUCES INTERNAL AND EXTERNAL AUDIT RISKS

  • Links and indexes entire product record, including the DMR and DHF for easy searching
  • Reduces risk of violations including warning letters and Form 483 observations

SIMPLIFIES SOFTWARE SYSTEM VALIDATION

  • Documents validation test results for every product upgrade to all subscribers
  • Reduces time and costs associated with developing and executing test cases

Learn how the seven principles of product-centric quality management simplify regulatory compliance.

FACE AUDITS WITH CONFIDENCE

Medical Device Audit

Arena QMS enables medical device manufacturers of Class I, II, and III devices to address FDA 21 CFR Part 820, Part 11, and ISO 13485 requirements. We help you gain control of your DMR, DHF, SOPs, and training records to pass internal or FDA audits.

“Although the Arena team was not involved in our FDA inspection, your solution helped us find and retrieve records quickly to address inspection requirements ahead of schedule. Thank you for supporting our needs and creating a solution that really works as promised!”

Michelle J. Potvin  ASQ CQA, Director, Quality Assurance & Regulatory Affairs, Swan Valley Medical

JOIN THESE INNOVATIVE CUSTOMERS

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