MEDICAL DEVICE AND DIAGNOSTICS

Simplify quality management and reduce supply chain complexity with digital and proactive quality management

Why the top medical device companies choose Honeywell

Hundreds of medical device manufacturers rely on Honeywell for our deep expertise in quality and QMS solutions to reduce risk and complexity of managing quality across the supply chain.

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WE KNOW THE INDUSTRY

Helping top companies effectively deliver quality products to market for over 25 years.

PROACTIVE QUALITY PLATFORM

Collaborate on quality events across your value chain from a single, robust platform.

CLOSING THE LOOP

From lab to post-market surveillance, gain actionable insights to minimize product quality and patient safety risk.

HOW OUR SOLUTIONS DELIVER VALUE AND IMPROVED OUTCOMES

DIGITAL QUALITY PLATFORM BUILT FOR INDUSTRY

Connect quality across the value from lab to post- market leveraging advanced digital technologies – cloud, AI/ML and IoT to gain real-time insights, faster response times and speed up time to market.

SIMPLIFY SUPPLIER QUALITY MANAGEMENT

Ensure supply chain continuity, reduce supplier-related recalls and risk and reduce product time-to-market with a single, integrated and digital QMS platform.

ENSURE COMPLIANCE AND MINIMIZE PATIENT RISK

Manage the entire complaint lifecycle using AI and a risk-based approach. From ISO 13485 to MDSAP, stay on top of evolving regulatory requirements. With efficient reporting capabilities like eMDR and EU MIR, ensure timeliness and accuracy of submissions.

Key QMS Capabilities

NONCONFORMANCE/CAPA

Manage and trend nonconforming products and resulting actions, with automated routing, notification, delivery, escalation, and approval capabilities.

RISK MANAGEMENT

Built-in templates comply with ISO 14971 for risk management throughout the entire product lifecycle.

SUPPLIER QUALITY MANAGEMENT

Manage and collaborate, from onboarding and auditing to ongoing performance management, with supplier chain management.

AUDIT MANAGEMENT

An integrated tracking system and a powerful workflow engine that automates audit findings, responses, corrective actions, approval, and reporting.

CHANGE CONTROL

Manage changes from requests, through pre-approvals, change execution, follow-up approvals, and implementation.

COMPLAINT HANDLING & REPORTING

Manage the entire complaint lifecycle— from complaint to investigation, root cause analysis, and regulatory reporting from a centralized and validated system. Learn about AI-enabled Complaints.

Life Sciences QMS

TrackWise Digital

Our TrackWise Digital^® QMS solution is an industry-leading quality management system with integrated modules that work together to support quality, compliance and more efficient and effective decision-making.

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TrackWise

TrackWise^® is the world’s leading on-premise QMS software. TrackWise offers several industry best-practice workflows, bringing all your quality processes together in a single place.

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QualityWise.ai

The world’s first AI-enabled capabilities specifically designed to improve quality and support Good Manufacturing Practices (GMP).

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