The Medical Device Accelerator (MDA) is a web based tool managing the medical device development lifecycle. MDA provides a configurable user interface tailored to the user’s preference. MDA provides instructions for performing each activity and access to resources needed.
All activities have schedule dates and status. MDA presents a graphical view of the process color coded to indicate the overall status. Activities can be mapped to standard and regulatory requirements (FDA Design Controls, ISO 13485, ISO 14971, IEC 62304 etc.) for compliance reporting.
Some key features are:
- Document Management - version control for documents.
- Scheduling - integrates with Microsoft Project and other scheduling tools.
- Defect Tracking - from initiation, assignment, implementation, verification and deployment.
- Complaint Management - track complaints from inception to closure.
- Corrective/Preventive Action (CAPA) - track Corrective and Preventive actions from inception to closure.
- Training Management - create, assign courses, track assignments and gather feedback.
- Reports - show project status, defects, training assignments, complaints, CAPAs and document approvals.
For more information contact us or see the Medical Device Accelerator White Paper.