ISO 13485:2016 Certification

ISO 13485:2016 Certification is an internationally recognized Quality Management System (QMS) standard specifically designed for organizations involved in any phase of the medical device development and production process. It emphasizes a process-oriented approach to ensure the design, safety, and quality of medical devices.

Obtaining ISO 13485 certification signifies that an organization has effectively established and implemented comprehensive processes across all medical and in vitro diagnostic device development, production, design, and servicing stages. This certification is relevant not only to medical device manufacturers but also to industries that support device manufacturing and those within the supply chain.

Our certification process involves a thorough evaluation by our experienced auditors to ensure that your management system meets the high standards of ISO 13485. This certification not only supports adherence to global regulatory requirements, including the UK Medical Device Regulations but also ensures that your products consistently meet the highest quality and safety standards in the medical device industry.