AOS Anterior Instructions for Use (IFU) & Intended Use Statement are available here in .pdf format.

QMS, Approvals and Regulatory information

AOS Anterior is registered as a Class I Medical Device (rule 12 MDD) as per MEDDEV 93/42/EEC of 14 June 1993, amended by Directive 2007/47/EC and the following harmonised standards;

  • EN ISO 14971:2012 Medical Devices - Application of risk management to medical devices
  • BS EN 62304:2006+A1:2015 - Medical device software - Software lifecycle processes
  • BS EN 62366-1:2015 - Medical devices - Part 1: Application of usability engineering to medical devices
  • ISO 15223 -1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
  • EN 1041:2008 information supplied by the manufacturer of medical devices