Overview
The aim of this module is to provide learners with a detailed understanding and requirements of a quality management system and how to design this under the CFR 820 or ISO13485 headings, as well as compliance assessment. The module will also examine strategic issues affecting the commercial maintenance of a medical technology product post-launch and an understanding of the skills required to control regulatory affairs departments, customer feedback and complaints.
Entry Requirements
All applicants will be considered on a case-by-case basis. Lifelong Learning reserves the right to require applicants to attend for an interview to determine their suitability for the programme