Troubleshooting Your Medical Device Quality Management System

The FDA sets the standards for quality manufacturing in the U.S., but in the EU, Japan, Canada and elsewhere, the ISO - specifically ISO 13485 - is the gold standard.

Like any quality standard, ISO 13485 offers its own unique challenges. The FDA's quality systems regulation and ISO are similar, but they do have differences. And failing to understand those differences can result in your products being banned from non-U.S. markets. ISO differs from the FDA in the following key areas:

• An increased focus on customers
• Greater attention to allocating resources and staffing
• More specific rules governing infrastructure and environment

Increased emphasis on maintaining a quality management system
Let Troubleshooting Your Medical Device Quality Management System help you bring your quality system into compliance with ISO requirements.

Troubleshooting Your Medical Device Quality Management System: A Compliance Guide for the EU, Japan, Canada and More is the management report that gives you the framework for reviewing your quality system to ensure conformity with ISO 13485, as well as tips for keeping your staff engaged in compliance. Plus, it includes the most commonly overlooked deficiencies that result in findings of nonconformance.

This report provides an overview of what's covered by ISO 13485, including its expectations for:

• Establishing and documenting a quality system
• Supporting quality
• Focusing on customers
• Establishing policies
• Planning and controlling a quality management system
• Carrying out reviews
• Allocating resources and staffing
• Infrastructure and environment

Failure to comply with the ISO standard will jeopardize your ISO certification and your ability to sell products in many markets. Troubleshooting Your Medical Device Quality Management System: A Compliance Guide for the EU, Japan, Canada and More will help employees of device manufacturers and their suppliers make sure that doesn't happen.

Place your order today and get:

• Key differences in ISO 13485 and the FDA's QSR requirements
• Six red flags to watch for that will instantly indicate you aren't meeting ISO 13485 requirements
• The four major pain points that every ISO 13485 certified company will have to address
• Tips to ensure the people running your facility stay in compliance with ISO 13485

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