Manus Neurodynamica, which develops and markets products and technologies for neuromotor assessment, has received ISO 13485:2016 certification following an assessment of its Quality Management System (“QMS”), validating the NeuroMotor Pen (NMP) manufacturing process as well as the organisation and its management procedures.
The accreditation and registration as a medical device manufacturer are significant milestones in the development of the company. It confirms that the internal processes as well as the formalised relationships, including suppliers and clients and regulators, are meeting the regulatory standards.
The QMS system defines a positive and self-organising culture. This achievement sets a solid foundation for launch into the clinical markets that enables commercial growth and having received this certification, the company can fully engage in commercial activities. These include: engaging with the NHS and purchasing hubs; easier engagement with reputable distributors and strategic partners; making adoption easier for pharmaceutical companies; preparing future submissions outside Europe; and launching with confidence in the US, once the first FDA approval has been obtained.
A total of £5 million of new funding has been raised to date, including a £750,000 financing round, closed in May last year, led by healthtech investors Par Equity with support from the Scottish Investment Bank, the investment arm of Scottish Enterprise, and Old College Capital. Manus had also received a £600,000 award from Innovate UK for diversification into Alzheimer’s and other dementias, and the overall project goal is to optimise and validate NMP for screening of Dementias.
Dr Rutger Zietsma, CEO of Manus, said: “We are so pleased to have been accredited with this ISO standard as it serves to recognise a key milestone in the development of the company. There is a natural sequence to the events that need to take place when taking a medical device to market and developing the organisation to support the launch and post-launch activities is crucial. Now all this essential work has been completed, Manus can fully engage in its commercial activities.”
