Medical Device
Regulatory
Compliance
Simplify FDA, EU MDR, and ISO Compliance
EXPEDITE READINESS FOR REGULATIONS AND REQUIREMENTS
To ensure patient safety, medical device manufacturers must establish and maintain quality systems to meet regulatory compliance requirements specified by the FDA, EU MDR, 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.
QUALITY
ASSURANCE TEAMS
follow closed-loop quality processes to improve traceability
REGULATORY
AFFAIRS
establishes strong design controls and ensures regulatory compliance
MANAGEMENT
TEAMS
improve adherence to training records, SOPs, and more
ENGINEERING
TEAMS
gain visibility to continually improve compliant designs
DOCUMENT
CONTROL
can prepare for and pass internal, ISO, EU MDR, or FDA audits
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’s 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
QUALITY TALK
Sanjay Banerjee, COO at Potrero Medical, shares insights about quality and compliance strategies.
FACE AUDITS WITH CONFIDENCE
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
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