Hymid is recertified to ISO13485:2016, the medical devices quality management system

We’re delighted that we have been recertified to the rigorous ISO13485:2016 medical devices standard.

The standard drives us to provide high quality, safe and effective injection-moulded medical devices and components. It’s globally recognised and demonstrates that we consistently meet customer and regulatory requirements, and can facilitate market approval of products for medical device OEMs.

Our Quality Manager, Tony Grocock, understands the value of a demanding audit and said: “It’s a tough certification to get through, but we know that having an independent auditor examining our quality department helps us to maintain the highest standards. We’re proud to have ISO9001, but also conforming to the medical ISO13485 standard, ensures that we are being pushed to provide the best possible service not only for our medical customers, but indeed for all of them.”

Tony with medical devices standard certificate

Putting ISO13485:2016 into practice

Hymid has the clean areas that enable us to make medical-viable, non-implantable devices. We have plans in 2021 for an ISO Class 7 clean room to further enhance this capability.

Acting as a development partner with a number of medical customers, Hymid provides the vital bridge between early development/prototyping of medical devices and mass production.

Our Managing Director, Tom McMurtrie added: “Our innovative and rewarding work with blue-chip pharmaceutical clients across a wide range of healthcare and medical projects is full justification for the effort put in to meeting this standard. We have undertaken some challenging projects, and it’s the level of continual improvement driven by our 7th successive year of ISO13485:2016 certification that helps us to be such a reliable partner for all our customers.”

For more information on the standard and our work in medical manufacturing, please contact us.