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.

“Mi3 has a customer focus culture and it is dedicated to helping solve issues and improve output quality. Medela AG has seen how Mi3 is passionate about assisting us to scale up the business”. 
Daniele Samuel Pascovici, Project Sourcing Healthcare, Medela AG

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.

Regulatory Services

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

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