Medical Device Compliance
Arena enables medical device manufacturers of Class I, II and III devices to address FDA regulations and ISO requirements. Using Arena you gain control of your device master record (DMR) and design history file (DHF), and efficiently manage your quality and medical device compliance documentation. With your evidence readily available you can confidently face audits from any safety or regulatory agency.
Free Medical Device Whitepaper
Beyond Colored Folders and Spreadsheets: Next–Generation Document Control for the Medical Device Industry
Medical device manufacturers face unique obstacles in effectively managing and securely sharing their product information. This whitepaper gives insight into how automated, electronic solutions can help medical device companies better manage their device master record (DMR), design history file (DHF) and change orders. Download the datasheet
With Arena, medical device companies can:
- Confidently achieve 21 CFR Part 11 and Part 820 compliance
- Manage their complete device master record and design history file
- Reduce change order cycle times
- Experience smoother FDA & ISO audits
How Arena helps
Arena enables medical device manufacturers to control their regulated products and processes through its product record repository and collaborative change management software. Arena helps medical device companies manage product compliance and control documentation including bills of material, design history files, device master records, and standard operating procedures.
Design control
Manage your design history files in a secure, centralized repository. With Arena, your team can easily locate product documentation, specifications and test reports to demonstrate compliant design control processes with ease.
Product control
Your device master records including all drawings, assembly procedures, and approved vendor/manufacturer lists (AVL/AML) are revision controlled in the Arena system. Any department from engineering, to purchasing, to manufacturing can access the product data securely and reliably from anywhere in the world.
Document control
With your standard operating procedures in one central location, everyone knows where to find the latest revision and has access to it. Changes to SOPs are managed in the same system as the SOP, so you can view the entire change history of a procedure and show the procedure to an auditor as well.
Process control
Standardize your change processes using specific forms and review board routings for each type of change — like ECOs, MCOs, and DCOs. Automatically notify stakeholders and key suppliers when changes take effect. Change orders have auditable change histories with implementation details and 21 CFR Part 11 compliant electronic signatures.
Audit ready
Confidently address audit inquiries with a highly traceable change management system and built-in compliance reporting. The Arena application has been audited by FDA inspectors during many successful customer audits. Several Arena customers have also successfully passed ISO certification audits by TUV, BSI and others.
Validation
Don’t waste time validating software — the Arena Validation Maintenance Service enables medical device companies to validate Arena software simply and easily. At every new release of Arena, your company receives a comprehensive software validation file including release notes with impact analysis, and executed IQ and OQ documentation, enabling you to always have the most up to date software with none of the validation hassle. Learn more…
Arena and medical device compliance regulations
Arena enables medical device manufacturers to meet their most pressing challenges, including compliance with the following regulations and standards:
- FDA 21 CFR Part 11
Electronic Records and Signatures: Arena provides secure and traceable electronic signature capabilities, allowing you to keep your records properly authorized, up to date and audit-ready at all times. Addressing the validation and process control requirements specified in this regulation is simple with the Arena Validation Maintenance Service. - FDA 21 CFR Part 820
Quality System Regulation: Arena provides a secure central repository for all your quality and design documents, including your device master records , design history files and approved supplier information. Traceable change orders and item histories provide audit-ready documentation of your design control processes. - ISO 13485
Quality Management Systems for Medical Device Companies: Arena enables ISO 13485 compliance, setting the stage for compliance with additional international standards, including the CE mark. With the secure web-based Arena system, your quality system can be utilized by all your offices around the world.
Arena customer spotlight: Align Technology
Align Technology is a Class II medical device company whose advanced orthodontic technology is subject to numerous FDA regulations. After experiencing rapid growth, the company chose Arena as a vital component of its continued expansion. Using Arena, Align experienced:
- A reduction in change order cycle time from 22 days to 3-5 days
- A $250,000 annual decrease in compliance administration cost
- A 300% increase in production document management efficiency
- Three successful ISO 13485 audits
The auditor was impressed with the traceability within Arena. With a click of the mouse, the complete revision history of any item can be displayed, including which ECO made the revision effective and who signed off.
Meredith Yost
Document Services Manager
Align Technology
Next Steps
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