NTU expands professional courses offering with new Medical Technologies Skills Academy

The Person Responsible for Regulatory Compliance course is the first in a new series of medical technology industry courses.

An example of medical technology manufacturing

NTU’s new Medical Technologies Skills Academy is launching a suite of professional courses, starting this autumn with the first virtual interactive training course Person Responsible for Regulatory Compliance (PRRC), which will take place over 12 hours across 20 and 21 September.

The course is aimed at medical device companies who operate within the EU and CE Mark dependant territories and now have to comply with new regulation laws which came into place on 26 May 2021, requiring these companies to now appoint a Person Responsible for Regulatory Compliance.

The 12 hours of interactive training will cover, among other aspects, the new Article 15 Medical Device and in vitro Diagnostic Regulations in full, while also outlining personal liabilities, and role-specific responsibilities. The course will then be followed up with 30 hours of additional reading, work, a 1-2-1 session with a course tutor, and finally, an assessment.

Professor Mike Hannay, Managing Director of the Medical Technologies Innovation Facility, explains the purpose of the new PRRC course.

Peter Rose, founder and CEO of medical device and quality regulation consulting company, PRQR has been appointed as the course leader and will implement his 28 years of experience and expertise in the medical device sector within the PRRC module content.

Additional course tutors include NTU’s own Mike Hannay, Managing Director of the Medical Technologies Innovation Facility, based at Clifton Campus.

Lateral Flow Tests are a medical device that has become common place during the COVID-19 pandemic

The Medical Technologies Skills Academy programme will be delivered in collaboration with the School of Science and Technology and the Medical Technologies Innovation Facility and taught by internal lecturers and external industry experts.

To find out more about the Person Responsible for Regulatory Compliance course or our Medical Technologies Skills Academy, please visit the course page or email mtsa@ntu.ac.uk.