|Mi3 Quality Management Systems are certified to EN
ISO 13485: 2012 and ISO 9001: 2008.
Mi3’s systems are constantly being developed to ensure
compliance to the most stringent standards within the
industry. We regularly celebrate zero non-conformance
audits from Notified Bodies and customers alike.
Compliance, for us, is a MINIMUM requirement.
Mi3 can CE Mark your devices to Class IIb Sterile, and
create and maintain your entire CE files for the life of
Mi3 will ensure your products are fit and safe for the
markets they enter. We are experts in the validation of
all the critical packaging, sterilization and transport
processes to ensure they match or exceed the
requirements of your customers and Notified Body.