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:
Reduce Cost Of Sales:
straightforward, it takes less time to earn your prospective customers’ trust and confidence.
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.