The process of medical device development from prototype to regulatory approval can be long and complex. Partnering with Mi3 can help remove the uncertainty.
We provide comprehensive medical device regulatory consulting services, with our Quality Management Systems (QMS) certified and audited to ISO 13485 via the Medical Device Single Audit Programme (MDSAP).
Up to Date and Compliant
Mi3’s systems are constantly evolving alongside the ever changing medical device regulations 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.
Meeting Your Requirements
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.
