- ISO 13485 : 2016 Annex II – Excluding Section 4 of MDD 93-42-EEC
- MDSAP: 2016 : https://www.cuda.com/wp-content/uploads/2017/08/Certificate-Annex-II-Excluding-Section-4-of-MDD-93-42-EEC-Expires-070121-SUNOPTIC.pdfISOhttps://www.cuda.com/wp-content/uploads/2017/08/Certificate-Annex-II-Excluding-Section-4-of-MDD-93-42-EEC-Expires-070121-SUNOPTIC.pdf 13485-2012 Certificate
- Declaration of Conformity: https://acrobat.adobe.com/link/track?uri=urn:aaid:scds:US:e0d0a758-6789-3120-a4d8-043aeab9b3cc