Services
We provide third party certification services to the following regulations and standards
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ISO13485:2016
This is a voluntary quality management system standard applicable to organisations that provide medical devices and related services. It is recommended in national guidance documents HTM01-01, WHTM01-01 and SHTM01-01 that Sterile Service Departments implement an ISO13485 compliant quality management system.
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Please note that we are in the process of obtaining accreditation from UKAS.
We are permitted in the interim to offer unaccredited certification services.
UK MDR 2002, Regulation 14
This is the UK regulation that is applicable to any organisations that "place medical devices on the [UK] market".
For SSDs, this means that any instrument set (or "procedure pack") that is assembled and ownership transferred to another legal entity, e.g., through loans to other organisations or by purchasing instruments on behalf of external customers. Reprocessing instrument sets belonging to another organisation does not automatically mean UK MDR applies to you!
SSDs who assemble procedure packs and transfer ownership are required to have the aspects relating to the provision and maintenance of sterility independently certified to Annex V and Regulation 14 of the UK Medical Device Regulations 2002, as amended by a designated UK Approved Body.
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Please note that we are in the process of obtaining designation from the MHRA and are not able to offer this service until designation has been granted.