Jeff McBride

European Device Solutions

Jeff McBride has over thirty years’ experience in ensuring that automated health care technologies are compliant with all current regulatory requirements.

Widely acknowledged subject quality and regulatory matter expert in mobile health applications. Utilising expertise honed through working with the ‘Clearblue’ brand of female reproductive health medical device products and with Biocartis, has been at the forefront of the proliferation of mobile applications or “apps,” beginning in 2012 with the device “Oncoassist,” the application becoming one of the first “Health Apps,” to be certified as a medical device authorised to affix the “CE” mark to their product. There followed subsequence success with other leading edge mHealth devices, Medopad, Hinge Health, Advanced Ophthalmic Systems, Atlas Biomed, plus many others.

Gaining regulatory recognition for clients Medical Devices from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, the Health Products Regulatory Agency (HPRA) in Ireland and Food and Drug Administration (FDA) in the USA and many other similar regulatory agencies worldwide.

Obtaining International Standards accreditation and certification for clients Medical Devices to ISO13485 and ISO27001.

As a result of his pioneering success in this market almost ten years ago, Jeff has been in ongoing demand from early stage tech entrepreneurs and development agencies including the UK DIT, Enterprise Ireland, and industry representative groups. As one of the principals of European Device Solutions, Jeff’s experience is now available to your company.