Australian-based reproductive biotechnology company Memphasys Limited (ASX: MEM) has achieved ISO 13485 (QMS) compliance (certification number MD 703870) for the company’s QMS.
ISO 13485 is the international standard for medical industry QMS systems, established by the International Organisation for Standardisation (ISO).
Having ISO 13485 certifies that the company meets the comprehensive medical device requirements set out in this standard.
The Memphasys QMS is implemented using the international, specialist “Greenlight Guru” software system.
Executive Chairman Alison Coutts said the QMS system enables Memphasys to manage product development, production, product distribution and sales, and post market product surveillance and support.
I am pleased that Memphasys has received this initial certification and that final certification is being processed,” Mr Coutts said.
“The ISO 13485 certification is extremely important as it provides international accreditation for our QMS. Its achievement not only supports product regulatory filings in high regulatory markets but will also assist with market access in low regulatory markets.”