Life Health Sciences
Medical Device Quality, Risk & Compliance Solutions
By
Jul 30, 2005, 18:55

Organizations in the Medical Device industry face a serious challenge – deliver safe, profitable products on-time, every time. Strict FDA oversight intensifies the pressure as companies struggle to get their products to market while fully meeting regulatory requirements. Failures not only result in 483s, consent decrees and product delays, but often erode a company’s public image affecting market share and profits. Finding ways to increase revenues, while maintaining compliance and high levels of product safety is essential to maintaining a competitive edge.

Pilgrim Software’s fully Web-based solutions help Medical Device organizations ensure product safety and enterprise-wide compliance with regulatory requirements, organizational SOPs and industry best practices. Built on more than a decade of domain expertise, Pilgrim Software’s Compliance Platform offers a powerful, fully integrated solution for internal/external assessments, nonconformance management, customer complaints, document management and SOP enforcement, employee qualification and certification, supplier quality, and equipment management.

Pilgrim’s 21 CFR Part 11 compliant solutions help medical device companies:

• Ensure an enterprise-wide state of control and predictable quality to ensure that regulatory and product safety requirements are fully met
• Take a risk-based approach to managing nonconformances, deviations and change management
• Reduce the cost of compliance, while fully meeting FDA requirements
• Provide the top-down enforcement of SOPs, Quality System Regulations (QSR) and ISO 13485/14971 requirements and best practices
• Improve profitability by reducing variability, eliminating waste, adhering to schedules and commitments and reducing cycle times
• Streamline FDA and other regulatory agency MDR reporting

Smart Results…
Pilgrim Software provides valuable Professional Services to help ensure staff of consultants provide everything from project management to system customization to validation – helping you minimize your risk and maximize your return on investment.

Some of Pilgrim's Medical Device Customers 

• Boston Scientific Corporation
• Cardinal Health
• Medtronic
• Millipore
• more

More Information

• Discover how Pilgrim helped Cardinal Health to streamline their processes in this free webinar
• Learn in this white paper how an integrated compliance solution can help your organization