Overview

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.

Some of Pilgrim's Medical Device Customers:

• Abbott
• Boston Scientific Corporation
• Cardinal Health
• Edwards Life Sciences
• Medtronic
• Millipore
• More Customers...

Resources

Customer Information

• Video Testimonial - Bob Dicheck, Osmetech Molecular Diagnostics
• Testimonial Transcript - Bob Dicheck, Osmetech Molecular Diagnostics
• Video Testimonial - Michele Donatich, Cardinal Health
• Testimonial Transcript - Michele Donatich, Cardinal Health
• Video Testimonial - Tom Britton, Millipore
• Testimonial Transcript - Tom Britton, Millipore
• Success Story - Cardinal Health
• Success Story - Millipore Corporation
• Success Story - Osmetech Molecular Diagnostics
• Success Story - Nucletron B.V.
• Success Story - Pall Corporation

Recorded Webinars

• World-Class ECQM Implementation - A Case Study with Millipore
• CDRH eMDR to be Made Mandatory. Are You Ready?

White Papers

• 21 CFR Part 11 White Paper
• 21 CFR Part 820 White Paper
• ISO 13485 White Paper 

Other Articles

• Medical Device Companies Honored for Advances (1.58 MB)
• The Future Is Here: Electronic Medical Device Reporting (971.4 kB)
• RAPS: GHTF Guidance Ignites Risk Management Concerns for ISO 13485:2003 (1.02 MB)