Medical Device and Diagnostics
Simplify quality management and reduce supply chain complexity with digital and proactive quality management
Accelerate Digital Transformation in Quality
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.
Sparta has helped top companies effectively deliver quality products to market for over 25 years.
Collaborate on quality events across your value chain from a single, robust platform.
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
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.
Ensure supply chain continuity, reduce supplier-related recalls and risk and reduce product time-to-market with a single, integrated and digital QMS platform.
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
Manage and trend nonconforming products and resulting actions, with automated routing, notification, delivery, escalation, and approval capabilities.
Built-in templates comply with ISO 14971 for risk management throughout the entire product lifecycle.
Manage and collaborate, from onboarding and auditing to ongoing performance management, with supplier chain management.
An integrated tracking system and a powerful workflow engine that automates audit findings, responses, corrective actions, approval, and reporting.
Manage changes from requests, through pre-approvals, change execution, follow-up approvals, and implementation.
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.