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System certification
Product certification
ISO13485 benefits

Your quality system's conformity with ISO 13485 can help you reap the benefits of:
  • 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 foster improved relationships with your suppliers, business partners and customers, and give your business a real advantage in the marketplace.
    
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