UMIP appoints Emergo as Regulators-in-Residence

UMIP, The University of Manchester’s IP commercialisation company, has appointed medical device consultancy Emergo Group as Regulators-in-Residence.

Emergo will provide regulatory support in relation to the development and commercialisation of University research projects related to medical devices and diagnostics.

The University of Manchester has an extensive track record in biomedical innovation and over the past 18 months, Emergo Group has been involved in providing regulatory input for a number of projects connected to UMIP.

In one case, Emergo has provided a formal regulatory opinion concerning an in-vitro diagnostic test kit intended to screen women at risk of developing cervical cancer.

Emergo Group senior consultant, Richard Love, will provide regulatory input via quarterly clinics with UMIP’s biomedical staff. Input would include medical device identification and classification as well as the key Regulatory and Quality Management System (QMS) requirements in primary markets such as the EU, USA, Canada and Australia.

Love said: “We are delighted to be associated with UMIP and this collaboration presents an exciting opportunity for Emergo Group.  We look forward to working with UMIP staff and to providing key regulatory support and guidance as these early-stage device and IVD projects evolve into commercial enterprises.”

Dr Rich Ferrie, Head of UMIP Biomedica, said: “We are very much looking forward to working with Richard and the Emergo Group team. Their extensive expertise will add significant value in shaping the regulatory landscape for our early-stage device and diagnostics technologies and will offer us a clearer vision of the requirements to take our technologies and products to market.”