12 November, 2019
We are pleased to announce our re-certification for ISO 13485:2016 as well as the European Council Directive 93/42/ECC – Annex V for medical devices. These certifications reaffirm that our quality management systems for producing medical devices consistently meet the applicable regulatory requirements.
ARANZ Medical’s CEO, Bruce Davey, says “these re-certifications reassure our customers that our medical devices are safe to use with their patients, and will continue to enable us to sell our products in many countries including within the EU, subject to meeting any local laws.”
What is ISO 13485:2016?
ISO 13485:2016 is an internationally recognized quality standard to ensure the consistent design, development, production, installation and sale of medical devices that are safe for their intended purposes.
What is European Council Directive 93/42/ECC?
The European Council Directive is part of a set of European laws that detail the essential requirements manufacturers and importers must meet to apply the CE mark and legally market or sell their devices in the EU.