We run various levels of process validation across IQ, OQ and PQ studies.
To support this activity, we have on site metrology capabilities and are certified to ISO13485.
CERTIFIED TO ISO13485
Our processes are controlled by an ISO13485 Quality Management System, certified by SGS / UKAS.
This ensures our documentation is consistent, repeatable and traceable, making us the perfect supply partner for medical device development.
Hymid has established close relationships with a range of highly qualified tool makers, both in the UK and overseas.
Our pilot tooling programmes have been refined to deliver quantified results that are robust enough to be fully validated whilst also allowing for further R&D type development work wherever necessary.
IQ, OQ and PQ validation studies can be individually tailored to each development programme and will include a range of options for you to choose from including all necessary jigs and fixturing, advanced metrology services (such as CT scanning & analysis), isolated CPK studies with documented protocols to support.
QUALITY + COMPLIANCE
All activity undertaken within the realm of medical device development is supported by our Quality, Compliance and Metrology teams.
We have a dedicated Class 7 cleanroom on-site, running a fully calibrated 2-shot Arburg injection moulding machine, which is also perfectly capable of running conventional single shot components.
We also have the capability to produce detailed measurement reports in-house, using our isolated Zeiss O-Inspect 322 CMM system.