A new notice from the European Commission allows audits to be performed remotely in light of current COVID-19 restrictions. Read more...
What does Brexit now mean? As we enter 2021 with a trade deal between the UK and the EU we discuss what this will mean for businesses within the medical device industry.
The challenges all manufacturers faced in 2020 were unlike any before. We discuss how Mi3 managed these issues and why choosing a contract manufacturing partner with a reputation for reliable supply is important for your business to succeed.
From incorporating device sterilisation into a full design and development project to utilising our 'plug and play' fully validated mixed load cycles, Mi3 can offer a breadth of sterilisation services.
Mi3's resident regulatory expert, Kelly Jackson, details the differences between MEDDEV and MDR regarding clinical evaluation, the potential deficiencies for approved products that must transition and any associated actions to take as a legal manufacturer.
Mi3 has launched a new series of white papers aimed at providing a comprehensive look at all the steps involved in the design, development and manufacture of medical devices. Learn more about the topics discussed and access our white paper repository here...
As demand for manufacturing in the UK surges across multiple industries, what are the benefits to partnering with a UK manufacturer for your medical device manufacturing?
Medical device classification is based on the risk associated with the use and enforced by law. It is important to get the classification determined early in the process in order to understand the regulatory pathway and requirements but what happens if your device is difficult to classify? Learn more...
Recent updates to FDA COVID-19 testing frequently asked questions now means that emergency use authorisation or EUA's for LDTs are no longer accepted. Learn more about what this decision means...
Student placements, or internships, provide valuable experience and increased employability for the student whilst also adding value to the business and the overall client experience. Our latest student, Muhammed Dassu reflects on his time at Mi3 and the new skills he has learnt. Read more...
The delay to MDR means the UK will no longer be in their transition period with the EU when the new regulations come into force in May 2021. Kelly Jackson discusses new guidelines issued by the MHRA on the regulation of medical devices being marketed within the UK. Read more...
With the ability to 3D print anything from a house to a bionic arm it’s difficult to know when, why and how to best utilise 3D printing. Mi3 Design Engineer, Mark Holme discusses incorporating 3D printing as part of your product design projects.
The date of application of the MDR has been postponed. click to read more...
Come and join us at Compamed/Medica 2019 - the world's leading platform for state-of-the-art medical technology!
We are proud to be attending MD&M East in New York on 11th and 12th June 2019. We would love to catch up with you there. Please feel free to contact us.
Mi3 achieves MDSAP Certification…which is great news if we manufacture the products you sell in Europe, Australia, Brazil, Canada, Japan and the US.
During 2018, Mi3 has undertaken a refinement of its brand, as a consequence of our work to identify our true Core Values.
