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 Mi3 Quality Management Systems certified and audited to ISO 13485: 2016 via the Medical Device Single Audit Programme (MDSAP).
MDSAP with Mi3
MDSAP is a single approach to auditing and monitoring the manufacturing of medical devices to be marketed in the following member countries; Australia, Brazil, Canada, Japan and the United States of America. Official observers of the programme include the EU and WHO Prequalification of IVDs Programme and new affiliate members Argentina and Korea; meaning Mi3 is well positioned to assist with medical device regulation requirements to launch a new product to key markets worldwide.
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.
Mi3 can provide:·
- Assistance with Device Files and MDR requirements
- Advice on CE marking of medical devices to Class IIb Sterile
- Assistance with the validation, certification and maintenance of the CE files for the life of the product.
- Maintenance of Device Files for the life of the product
- Design & Development documentation
- Process, Sterilisation, Packaging and Transit validations
- Ever evolving to ensure compliance with new regulations, including MDR and UKCA mark