UPDATE: We had our 3 year audit in December 2020 and are recertified now until 2023!
Here at Hymid, we’ve recently been re-assessed against the latest ISO13485 (Medical Devices) standard; ISO13485:2016, and are pleased to announce that we have passed the audit successfully. ISO13485:2016 is the latest version of the internationally recognised quality management systems standard for the medical device industry. It provides an effective framework for manufacturers and service providers to demonstrate their compliance with regulatory requirements. This was our first surveillance audit undertaken to the new 2016 standard which places greater emphasis on the management of risk. It is an essential pre-requisite for us to be allowed to work with medical device companies as their development and supply partners.
“This is a really positive step for Hymid and our clients. This certification aligns with our ethos of ensuring that excellence is instilled throughout everything that we do, and demonstrates that our manufacturing capabilities are of the highest standard. Well done and thank you to everyone involved in delivering a successful result.” Tom McMurtrie, -Hymid’s Managing Director