ISO 13485 MEDICAL DEVICE CERTIFICATION Audits

Safety and quality are non-negotiables in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a product’s lifecycle, including service and delivery. More and more, organisations in the industry are expected to demonstrate their quality management processes and ensure best practices in everything they do.

For more information, download the ISO’s free tips for getting started with ISO 13485, requirements for quality management systems related to medical devices.

ISO 13485 is an internationally recognized standard that establishes quality management system requirements for medical device and equipment manufacturers. Its primary aim is to harmonize and streamline quality management processes to meet regulatory demands in the medical devices sector.

Key Benefits of ISO 13485 include ensuring compliance with regulations, demonstrating the safe production of medical devices, and expanding market access to boost device sales. Moreover, obtaining certification offers further advantages such as reduced operating costs, improved stakeholder relationships, legal compliance, enhanced risk management, proven business credentials, access to new markets, and increased customer satisfaction.

Structured similarly to ISO 9001, ISO 13485 serves as the foundation for regulatory compliance in local and most export markets, showcasing a commitment to meeting customer requirements. Manufacturers, suppliers, distributors, and those involved in medical devices can apply for ISO 13485 certification. However, in some markets, additional local regulatory certification is necessary alongside ISO 13485 to legally manufacture and sell medical devices. The standard entails specific requirements for manufacturing, installation, and servicing, including a risk management approach to product development and realization, process validation, adherence to statutory and regulatory obligations, effective product traceability and recall systems, and the implementation of an enhanced quality management system.

UKAS CertCheck

The UKAS CertCheck is a global database where users can search and validate the status of accredited certifications issued by a Certification Body which has been accredited by UKAS.

This means that anyone can validate an organizations certification(s) confidently knowing, the certification is valid, the Certification Body is UKAS accredited, in real time, all in one process.

Validate a Certificate here.