Quality Management Solutions for the Medical Device Industry
In a rapidly growing and highly competitive landscape, medical device and diagnostic manufacturers face unique industry challenges, including shorter product lifecycles, increased regulatory scrutiny, and the need to manage strategic partnerships across the value chain.
Sparta Systems offers medical device companies specific industry solutions that reduce the complexity of regulated business processes while reducing costs associated with production, design, and customer service. Our expertise in the medical device industry is gained from implementing best-of-breed solutions in over 50 medical device companies, including seven of the top ten medical device manufacturers.
TrackWise Enterprise Process Management Software
TrackWise is a web-based enterprise quality management software solution that enables your organization to comply with 21 CFR 11, 21 CFR 820, GMP, ISO13485, ISO 9000, and other industry standards. TrackWise is the only solution that provides centralized and consolidated tracking, workflow management, and reporting for all critical business processes. TrackWise enables medical device manufacturers to achieve unprecedented compliance results by consolidating redundant systems, reducing manual operations, and implementing best-of-breed technology.
Select a TrackWise solution from the list below:
Industry Solutions
- Quality Management
- Nonconformance Management, Customer Complaint Management & Medical Device Reporting, Supplier Quality, Internal and External Audits, Change Control, Corrective and Preventive Actions (CAPA), Calibration and Preventive Maintenance
- Training Management & Employee Qualifications
- Document Management & Changes
- Clinical Trials Management
Corporate Solutions
- Environmental, Health & Safety
- Incidents, Risk Assessments, Audits & Inspections, Process Safety Management, Occupational Health & Safety
- IT Service Management
- Change Control, Incident & Problem Management, Project & Action Item Tracking
- HR Management
- Grievances & Complaints, Applicant Tracking, Personnel Tracking
- Governance, Risk & Compliance
- Internal Assessments, Incidents & Investigations, Change Management, Corrective Actions
- Action Item Tracking
