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INDUSTRIES WE SERVE

Designed for Complex
Technology Products

MEDICAL DEVICES

Design Safe, Innovative, and Compliant Products

Medical device manufacturers face many challenges to successfully deliver innovative and safe products while complying with FDA and ISO quality system regulations. Traditional document-centric quality management tools fail to manage the full product record or complete bill of materials (BOM).

Arena’s product-centric quality management system (QMS) connects quality and product development processes into a single source of truth to simplify regulatory compliance and speed commercialization.

INDUSTRY CHALLENGES

Medical Device Robotics

Arena QMS addresses these key challenges:

Silos of product and quality records
Disconnected quality, engineering, operations, and partners
Issues creating design controls to comply with quality system regulations
Problems creating and tracking product requirements through design output
Quality and product issues stemming from poor training processes

HOW WE HELP

Arena QMS benefits include:

Unifying quality and product record management to improve control and traceability

Addressing quality issues earlier with product BOM visibility

Assuring continuous compliance with FDA 21 CFR Part 820 / Part 11 and ISO 13485

Establishing and maintaining strong design controls to simplify compliance

Decreasing audit risks and simplifying audit processes

Identifying, analyzing, and resolving quality issues with closed-loop CAPA processes

Medical Device Technician

CUSTOMER SUCCESS

Providing a Single Quality Management Solution

“Arena can do it all: manage your bill of materials (BOM), quality system, documents, device returns, nonconformance, and your entire CAPA.”

– Kim Khoe, Director of Regulatory Affairs and Quality Assurance, Apical Instruments

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MEDICAL DEVICE COMPANIES TRUST ARENA