Medical Device

Medical Device Overview Brochure

Enterprise Quality Management Software for the Medical Device Industry

In a rapidly growing and highly competitive landscape, medical device and diagnostic manufacturers face countless unique industry challenges, including shorter product lifecycles, increased legal and regulatory scrutiny, and the need to manage strategic partnerships across the supply chain.
 
Sparta Systems’ software helps organizations mitigate risks and reduce the complexity of regulated business processes while lowering the costs associated with the production, sales, and service of medical devices and diagnostic products.
 
Sparta’s best practices and domain expertise enables organizations to effectively comply with regulations that include 21 CFR Part 11, 21 CFR Part 820, GMP, ISO13485, ISO9000, and other industry standards.

Since 1994, Sparta Systems enterprise quality management software (EQMS) solutions have been successfully enabling companies of all sizes to achieve unprecedented gains in efficiency by consolidating redundant systems, reducing manual operations, and implementing operational best practices.  Leading device manufacturers worldwide rely on Sparta’s EQMS to manage, track, and report on incidents to help ensure compliance with regulatory requirements, manage the supply chain, and reduce cycle time and time-to-market.

EQMS-med device 

Complaint Handling & Regulatory Compliance Software

Implement a global and consolidated approach to managing customer complaints and medical device reporting, including eMDR and eMDV.

Nonconformance

Track and manage all phases of the product nonconformance process with Sparta Systems' nonconformance software, from the initial report to the investigation and root cause analysis to any resulting actions and follow-up verification.

Corrective Action and Preventive Action (CAPA)

Develop a repeatable, compliant, and closed-loop CAPA process that logs and manages quality issues originating from any source to help drive next generation design changes.

Supplier Quality Management

Manage the process of qualifying, selecting, and monitoring suppliers and supply chain partners using features such as supplier scorecards, supplier qualification workflows and tracking systems for supplier nonconformances.

Audit Management

Identify and mitigate operational and compliance risks by efficiently managing the full audit lifecycle, including the resolution of findings in a timely and effective manner for internal, regulatory and supplier audits.

Risk Management

Integrate risk management processes across a company’s entire quality management system, ensuring that nonconformities, regardless of source, are evaluated using consistent criteria to determine risk prior to escalation to CAPA.

Contact Sparta Systems today for more information on our enterprise quality management software solution for medical device organizations.


Click here to learn more about Sparta Systems' enterprise quality management system TrackWise.

Click here to learn more about Sparta Systems' cloud enterprise quality management solution 123Compliance.

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