• Expanded market access
  National regulatory authorities require, or strongly prefer, that manufacturers marketing medical products in their countries have a third-party audited and certified quality system in place. Investing in such a system speeds access into those countries that require it, and expedites market entry into the others.
• Reduced cost of sales
  Your certification establishes your company's credibility and commitment to quality from day one. Because the task of explaining the specifics and demonstrating the effectiveness of your quality system is more straightforward, it takes less time to earn your prospective customers' trust and confidence.
• Improved overall performance
  Based on a uniform and widely accepted system of process control, your certified QMS helps you improve your products and processes. This can faster improved relationships with your suppliers, business partners and customers, and give your business a real advantage in the marketplace.

Other specific differences include:

• The promotion and awareness of regulatory requirements as a management responsibility. An example of market specific regulatory requirements is 21 CFR 820 Quality System Regulation for Medical Devices sold in the United States.
• Controls in the work environment to ensure product safety
• Focus on rick management activities and design transfer activities during product development
• Specific requirements for inspection and traceability for implantable devices
• Specific requirements for documentation and validation of processes for sterile medical devices
• Specific requirements for verification of the effectiveness of corrective and preventive actions.

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