Mi3 Quality Management Systems are certified and audited to ISO 13485: 2016 via the Medical Device Single Audit Programme (MDSAP).

We are constantly developing our systems 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 advise clients on the CE marking of medical devices to Class IIb Sterile, and can assist with the maintenance of the CE files for the life of the product.

Quality, Validation and Certification

Mi3 will ensure your products are fit and safe for the markets they enter. We have expertise in the validation of all the critical packaging, sterilisation and transport processes to ensure they match or exceed the requirements of your customers and Notified Body.