Hurdle (a Chronomics Ltd. brand), a global provider of R&D and remote health testing solutions for life sciences, healthcare providers, employer benefits consultants and employers, is proud to announce that the company has been recommended for the ISO 13485 certification.

The ISO 13485 certification demonstrates that Hurdle’s (a Chronomics Ltd. brand) quality management system complies with the recognised international standard for designing, developing and distributing medical devices and supports a medical device manufacturer’s quality management system to satisfy the requirements of multiple regulatory authorities.

“This is a key milestone for Hurdle (a Chronomics Ltd. brand),” said Hurdle Vice President of Compliance Dave Russell, who led Hurdle’s ISO certification program. “The achievement is a testament to our team’s high-quality, cross-functional and collaborative effort. I sincerely thank everyone for their efforts.”

What is ISO 13485?

ISO 13485 is the medical industry’s optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. ISO 13485 certification is essential in keeping professionals and customers safe in clinics, hospitals and other medical settings.

ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonised medical device regulatory requirements. The standard contains specific requirements for the manufacture, installation and servicing of medical devices and calls for the following:

• Implementation of a Quality Management System with several enhancements
• Risk Management approach to product development and product realisation
• Validation of processes
• Compliance with statutory and regulatory requirements
• Effective product traceability and recall systems

This standard allows companies to reduce safety and legal risks while creating more economical work environments. Furthermore, as an internationally recognised standard of quality and safety for medical device manufacturing, ISO 13485 certification helps companies become more reputable, trustworthy providers. The most recent version of ISO 13485 is reviewed every five years and revised according to the new requirements and needs of the industry.