Development of Medico, Life Science and medical equipment at Move Innovation
Life Science is a growing field which is, among other things, due to increased ageing and increased population. In Denmark, the Life Science sector exported more than DKK 150 billion. DKK in 2020. The sector's need for the development of unique and innovative certified solutions has led to long-term collaborations between Move Innovation and a number of Life Science companies since 2009.
Today, 50% of Move Innovation's revenue comes from the development of electrical Life Science Devices.We develop disposable electronic equipment, sensitive sensors, telemedicine (also 5G solutions) and IoT equipment, which place high demands on the environment, recycling, GDPR and compliance with the Medico standards.
We have been involved in developing IoT databases, equipment and medical instruments under the FDA, MDD (phased out by the EU) and MDR standards. We always use our and our customer's skills in jointly optimised project teams, so we are able to meet deadlines, technical requirements and authority requirements.
The authority requirements provide an additional certification dimension when developing medical devices. Requirements that must be considered from the start of the development project. The aim is to prove in detail that the equipment does not pose a danger to the users. Directives and standards such as the Machinery Directive, the Low Voltage Directive, DS/EN 60601, DS/EN/ISO 13485 and DS/ISO 14971 are a big part of our everyday life when we develop medical equipment.
Medico equipment must be approved by the authorities before it is put on the market. In EU, we use a CE marking, which is divided into the following classes: I (Is, Im), IIa, IIb and III as well as Active Implantable Medical Devices (AIMD) and in Vitro Diagnostic Devices (IVD).
Each class has its own requirements. The purpose of the labelling is primarily to document high safety and low risk for the users, and to prove the product is effective in relation to the intended use.
The projects often start with determining the risk plan and the content of the quality management system in relation to the intended use and classification.
After this, we look at the phases of the development project and the organisation of the project in relation to the requirements in the quality management system.
In certain cases, it is desirable to introduce critical suppliers with associated auditing processes, which are not contained in the QMS system.
Move Innovation is used to taking on the role of critical supplier to Medico companies.