Medical Device and Diagnostics

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

Accelerate Digital Transformation in Quality

The rise in product, process and supply chain complexity has accelerated the need for digital transformation to collaborate and minimize risks across an expanding network of suppliers meet patient expectations. TrackWise Digital provides a robust platform to accelerate product release and responsiveness using advanced capabilities – AI, ML and IIoT to optimize operations, increase throughput and put quality at the forefront of every process.
 

Why the top medical device companies choose Sparta

Hundreds of medical device manufacturers rely on Sparta 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

Sparta has helped 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 to manage risks throughout the entire product lifecycle.

SUPPLIER QUALITY MANAGEMENT

Manage and collaborate with suppliers and contract manufacturers, from onboarding and auditing to ongoing performance 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.

Sparta Systems 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. Learn more
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. Learn more
QualityWise.ai
The world’s first AI-enabled capabilities specifically designed to improve quality and support Good Manufacturing Practices (GMP). Learn more

Let’s talk about how
TrackWise Digital can work for you

No matter where you are in your quality management digital journey, Sparta has solutions for you