ISO 13485 – Medical Device Quality Management System Standard

ISO 13485 is the quality management system standard for medical device manufacturing organizations.

Oxebridge partners with an ISO 13485 and US Food & Drug Administration (FDA) expert for the provision of ISO 13485 implementation. Under this implementation program, you can ready your company for third-party ISO 13485 certification while ensuring compliance with appropriate medical device regulatory requirements, such as FDA.

For existing Oxebridge ISO 9001 clients, additional savings are available.

To obtain a quote for ISO 13485 from Oxebridge, contact us today.