Why Mi3?

The medical devices sector provides an expansive breadth of instruments, appliances, implants or reagents for specific medical purposes in the prevention, diagnostics, treatment, monitoring or alleviation of diseases.

The process of designing and getting a medical device to market can be a complex one, and success can be masked by layers of regulations. At Mi3, we believe the decision to outsource the design, device development, the manufacturing or the entire process should be as easy as possible and provide you with a trusted partnership for the journey.

The design and development of a medical device at Mi3 follows 7 key phases. Moving between phases within a design project or complex design activity with a stage gated review at each step alongside detailed design inputs and deliverables throughout the entire process and resulting in a seamless collaboration between Mi3 and our clients.

The team at Mi3 work closely with you to ensure your medical device, be it simple or complex, is designed and developed to meet the scope of its intended use and the needs of the end user in a cost effective and timely manner.

Medical devices for marketing in the UK and EU are currently subject to regulation under the EU’s Medical Device Directive(93/42/EEC) which is soon to be replaced by the Medical Device Regulation(MDR) in May 2021. For more detail on the regulatory consulting services Mi3 can provide in conjunction with your design and development project click here.

In Vitro Diagnostic devices are a sub group within Medical Devices. The sector alone is an industry that is essential to improving outcomes for the NHS and other frontline healthcare services, and Mi3 is committed to partnering with diagnostic device companies in their development of new innovative IVDs.

The design and development of an IVD at Mi3 follows the same 7 key phases seen in our medical device development process. Moving between phases within a design project involves a stage gated review at each step with detailed design inputs and deliverables.

The team at Mi3 work closely with you to ensure your device, be it simple or complex, is designed and developed to meet the scope of its intended use and the needs of the end user in a cost effective and timely manner. The relevant IVD regulatory requirements are considered every step of the way.

In vitro diagnostic medical devices (IVDs) are subject to the European Directive 98/79/EC (IVDD). A subgroup of medical products, their market access, use, and market surveillance is regulated. The IVDD is implemented in the national laws of the member states and will soon become the IVDR in May 2022. For more details on how the UK’s departure from the EU will affect the regulatory requirements for IVD products being sold into the UK and/or EU click here.

In general, biotechnology can be determined as technology that is based on biology or science. Harnessing the many cellular and biomolecular processes, and translating them into technologies and products that can help improve our lives, is the challenge of the thousands of biotechnology companies across the globe.

Mi3 can help remove some of the complexity involved in developing these new products, and make innovations happen. We help biotech equipment companies transform design concepts, lab-scale processes and technologies into robust, marketable devices.

Our experience and design insights are invaluable in specifying the appropriate product development process for you. Speeding up development and helping prevent costly mistakes, as well as precision testing and validation equipment.

Leanna is the Research and Development Manager at Mi3 and overseas the onboarding of all new products at Mi3 she has over 7 years’ experience specialising in medical devices within industry within R&D, Technical and Manufacturing settings, covering the full product lifecycle from concept to post launch.