Design Controls
Drive Compliant
Product Design Controls
JOINING INNOVATION WITH COMPLIANCE
Medical device companies and their supply chains are more dispersed than ever. Everyone involved in new product development and introduction (NPDI) needs to share, review, and use the latest product and quality information to ensure safe and effective products can be built as designed. And, all processes must comply with the FDA and other regulating bodies.
Arena manages the key elements of design controls while accelerating innovation. Your quality, engineering, and operations teams can quickly establish, document, and follow compliant procedures.
EFFECTIVE DESIGN CONTROLS ENHANCE YOUR AUDIT CONFIDENCE
Developing medical devices requires adherence to FDA, EMA, ISO, and other regulations. Arena’s design control capabilities simplify your review, verification, and validation processes. Arena QMS speeds design changes and transfers by establishing and tracking design control elements: user needs, design inputs, design processes, design outputs, and device documentation.
QUALITY
TEAMS
link CAPA processes with the product record to close the quality-to-product loop
REGULATORY COMPLIANCE TEAMS
demonstrate that design controls processes are established and followed
DESIGN
TEAMS
create, modify, and share the latest design outputs for review, verification, and validation
SYSTEMS
ENGINEERING
manages dynamic user needs as requirements and links them with design inputs and outputs
SUPPLY CHAIN PARTNERS
have role-based controls to securely review and approve product releases and changes
OPERATIONS
TEAMS
review and analyze proposed product designs for DFM consideration
Simplify Compliance and Eliminate Audit Anxiety
Arena’s solutions helps you establish strong design controls to give your teams the confidence needed to face audits.
EXPERIENCE
AUDIT CONFIDENCE
- Arena enables design controls compliance
- Auditors can easily find evidence that compliant processes are established, documented, and followed
REDUCE CONFUSION
AND MISTAKES
- Connected quality and design extend throughout the entire supply chain, mitigating challenges created by dispersed teams
- Centralizing the BOM, DHF, and DMR with associated product design and quality records keeps everyone on the same page
CONTROL ACCESS TO
YOUR ENTIRE DESIGN
- Revision-controlled item and BOM information is linked to related engineering changes, quality actions, manufacturers, and suppliers
- Create, modify, and securely share product designs with quality, operations, and suppliers for cross-functional review
ESTABLISH COMPLIANT DESIGN CONTROLS
Medical device companies know that effective design controls lead to high-quality products. With Arena, your product teams can establish, document, and follow compliant design controls. This enables teamwide visibility into your product and quality records. Arena QMS provides the necessary design controls to help you deliver innovative, compliant medical products fast.
“We incorporate risk management throughout the design controls process per 21 CFR Part 820.30. Risk management starts early in the design process, when user needs and design inputs are defined. This early identification of risks helps us manage and deliver successful design verification and validation results.”
Vis Ayer Senior Director, Nevro
JOIN THESE INNOVATIVE CUSTOMERS
