ISO 13485 is a stand-alone Quality Management System (QMS) standard for Regulatory Purposes, sets the basis for a quality management system for organizations involved in the life-cycle of a medical device. Certification demonstrates your commitment to meeting your customers’ requirements and supports regulatory compliance in many jurisdictions.
ISO 13485 is applicable to any medical device organization, 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). It can also be used by suppliers or external parties that provide products, including quality management system-related services to such organizations.
It is applicable to all types of organizations, whether public or private sector, regardless of the type, size and nature of the organization or geographical location. It is a basis for such organizations to demonstrate their ability to meet customer and applicable regulatory requirements.
Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you to improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.
- Increase access to more markets worldwide with certification.
- Outline how to review and improve processes across your organization.
- Increase efficiency, cut costs and monitor supply chain performance.
- Demonstrate that you produce safer and more effective medical devices.
- Meet regulatory requirements and customer expectations.