Following a successful recertification audit in Jan 2023 our latest ISO 13485:2016 certificate can now be downloaded using the link below.
The following information relating to Safety and Performance relevant to the user, or any other person, is supplied in accordance with the Medical Device Regulations 2017/745, Annex I General Safety And Performance Requirements, Chapter III Requirements Regarding the Information Supplied with the Device, 23.1. General requirements regarding the information supplied by the manufacturer.
Please note these may not constitute the complete user instructions for use, for full Instructions for Use please see documentation supplied with the device.
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