Associate Software Consultant
I have vast experience in FDA, EMA, & MHRA regulated life sciences industries in the UK, Ireland, US, Far East and Mainland Europe.
I specialise in representing clients for the CE Mark or FDA Approval for medical devices that are solely/predominantly software.
Often start-up companies, small or medium enterprises find the prospect of having to meet what appear to be quite onerous regulations quite daunting, and have an impression that the regulatory requirements will introduce a bureaucratic burden into their business that they will struggle to cope with. Also, the various regulations and guidelines appertaining to the quality of such medical devices require that the company developing and/or selling these devices has an ‘Independent Quality Unit’. Often this means that the innovators within such companies are reluctant to address this issue and decide, against the best interests of their business, to postpone gaining the CE Mark or FDA Approval for their medical devices.
I recognise this and have developed a methodology by which the potential costs and bureaucratic burden can be managed and kept to within the constraints of the financial and resource issues of such companies. Whilst ensuring that the necessary requirements for having a Quality Management System and Technical File for your device are maintained to the highest quality and contain the information necessary to attain and retain the CE Mark or FDA Approval.