Risk Management
Medical device firms have begun to implement design level hazard analysis as part of the design control program, but ISO 14971:2006 ushers in the expectation that risk management is a life-cycle commitment. Now more than ever, medical device development teams need to understand all the factors that play a part in Risk Management for medical devices.
Paladin Medical guides you through design hazard analysis, user risk analysis, process FMEA, Fault-tree analysis, complaint analysis and trending, corrective and preventative actions (CAPA), management reviews and quality audits. We'll show your teams how Risk Analysis supports and improves new product development planning (Design Controls) and new product submissions.
For specific experience details and project profiles, please see the Paladin Medical Profiles in Success (pdf).
Paladin Medical Key Services
• Compliant Design and Development Control procedures.
• Implementation in conformance with FDA QSRs, ISO 13485:2003, and ISO 14971:2006.
• Independent reviewer for Design Review meetings.
• Develop and review risk management programs.
• Design History File and oversight of timely review and documentation.
• Risk Analysis support to new product development planning and regulatory submissions.
• Optimize risk mitigation.
©2008 Paladin Medical, Inc.
Design Control and Risk Management
Design Control Planning and Review
Paladin Medical, Inc. works with clients to establish compliant Design and Development Control procedures. At the root of all successful regulatory submissions is a well organized Design Control and Review system. Design Control is much more than writing a change order. Compliant medical device development begins with customer inputs and works through hazard analysis, validation and verification, soundly crafted output documentation and thorough design transfer and process validation. This requires a documented development plan and methods that show the product development process.
Revised FDA-GMPs, known as Quality System Regulations (QSRs), and ISO 13485:2003 require documented design review according to written procedures, with results maintained in a documentation system. Design plans, design review meetings, and change control for documentation of changes to design inputs and outputs, require sound methods for document maintenance in a Design History File.
