Predisys Medical Device Suite

Medical device manufacturers must operate within a strict regulatory framework. They experience strong pressure from regulatory bodies to maintain and improve quality and compliance, while simultaneously striving to maximize asset utilization and reduce costs.

As a solution to the need to reduce quality risks and regulatory concerns while improving efficiency, many manufacturers endeavor to implement quality and statistical methodologies, such as Lean Six Sigma and Statistical Process Control, across the enterprise. Taking full advantage of these methods can help manufacturers understand and control their manufacturing processes, enabling them to successfully achieve their quality targets.

Predisys Medical Suite is a modular, integrated solution that helps medical device manufacturers improve products, optimize processes and reduce costs while maintaining regulatory compliance. The Predisys solution offers a unique enterprise-class application suite for the Microsoft SharePoint platform. It provides an easy and intuitive user interface for fast user adoption and allows manufacturers to abolish paper based records and implement a paperless system.

Boosting Productivity through Paperless Records Management

Managing paper based records is a major cost for most organizations. The Predisys solution abolishes paper and provides electronic records management with digital signatures and audit trails for reduced data entry and processing errors, faster information exchange and cost savings resulting from less storage space. The paperless records management is a true catalyst for change and savings that helps those companies who are able to recognize its potential to transform manufacturing.

Integrated Quality Management System Improves Efficiency

Predisys Medical Device Suite provides organizations with an easy-to-use, centralized quality management system, which enables them to meet industry demands for managing deviations, non-conformance, supplier quality, internal and external audits, corrective and preventive actions (CAPAs), and other related quality issues. Predisys Medical Suite enforces compliance with standard operating procedures, and enables you to take proactive measures to improve quality operations.

A Catalyst for Change and Savings

Predisys Medical Device Suite is a comprehensive, modular application suite for cost- and quality conscious manufacturers providing:

• Batch and Device History Records
• Device Master Records
• Corrective and Preventive Action
• Supplier Corrective Action Requests
• Quality Audits
• Nonconformance Management
• Design Failure Mode and Effects Analysis
• Process Failure Mode and Effects Analysis

For manufacturers seeking further improvement Predisys Medical Device Suite can be extended with the following optional quality control modules:

• Statistical Process Control
• Statistical Engineering
• Measurement System Analysis