What is ISO 13485 Certification and Its Needs for Your Business?

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ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

ISO 13485 certificates are issued by independent firms authorized by national Ministries of Health to conduct audits of manufacturers quality systems. ISO 13485 certificates are never issued by a Ministry of Heath itself. 

Benefits of ISO 13485:

  • Expand Market Access:
National regulatory authorities require or strongly prefer that manufacturers marketing, medical products in their countries have a third-party audited and certified management system in place. Investing in such a system speeds access into those countries that require it, and expedites market entry into the others.
  • Reduce Cost Of Sales:
Your certification establishes your company’s credibility and commitment to quality. 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.
  • Improve Performance:
Based on a uniform and widely-accepted system of process control, your company’s certified management system helps you improve your products and processes. This can foster improved relationships with your suppliers, business partners, and customers, and gives you a real advantage in the marketplace.
ISO 13485
registration allows the company to focus its research and understand its roles, rights and authorities.
BarileConsulting Services LLC helps business organizations throughout the United States with ISO13485 Consulting. To know more about our ISO certificate consulting services, check our business website today. You can also dial (440) 628-8271 to get instant help from our service executives.