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 packagingsterilisation 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
- 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

What is MDSAP?

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 most recent 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.

Resource Centre

Mi3 News

The Benefits of MDSAP Acreditation

While there are approval routes that don’t require your devices to be developed and manufactured under an ISO 13485 quality management system,…

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Your free guide to current MDR Classification Rules

The classification of medical devices has changed with the implementation of the EU MDR. See how you’re affected in our handy infographic and complete guide.

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Mi3 News

Regulatory Update - Remote Audits for EU MDR/IVDR Certificates

A new notice from the European Commission allows audits to be performed remotely in light of current COVID-19 restrictions. Read more...

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