The Quality and Regulatory team is pleased to announce that Intertek will serve as our new Registrar. Graham-Field’s 2019 certification will comply with ISO 13485:2016 standards under MDSAP (Medical Device Single Audit Program).
The change in registrars and auditor availability have delayed our recertification. Please be assured that certificates will be posted as soon as they are received from Intertek. In the interim, we have posted a letter from Intertek confirming our audit schedule. View letter
This certification provides a critical building block for our continued growth in the medical device market and is yet another example of our ongoing dedication to quality.