UMIP appoint Emergo Group as Regulators-in-Residence
UMIP, The University of Manchester’s IP commercialisation company, has appointed Emergo Group, a leading medical device consultancy, as Regulators-in-Residence. Emergo Group 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, and in one case 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.
Richard commented, “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. More than 90% of our clients are small to medium size companies so we understand their needs and challenges very well.”
Dr Rich Ferrie, Head of UMIP Biomedica, said that he was delighted that Emergo Group had agreed to accept the appointment. “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.”