Jan 2020 – EyRIS is pleased to announce that we has successfully undergone Phase 1 & 2 of EN ISO 13485:2016 audit by TÜV SÜD that was conducted across 2 days.
The EN version required additional annexes to ensure compliance to quality management system clauses stated in the Medical Device Directive (MDD 93/42/EEC) Annex II. In addition, the product technical documentation was beefed up to comply with IEC 62304 (software), IEC 62366 (usability) and cybersecurity. The MDD requirements also demanded proof of product validation via Clinical Evaluation Report (CER). The CER were compiled and signed off by evaluating clinicians. This exercise ensures the harmonisation of our operational capability to the laws related to medical devices within the European Union.
We would also like to thank ARQon, our regulatory consultancy partner, for their sterling effort in helping EyRIS achieve this milestone.