Master the quality systems that power the medical technology industry
Are you ready to become an essential player in medical device regulation? This specialised certificate programme equips you with the expertise to design, implement, and manage quality management systems that meet both CFR 820, ISO 13485 and ISO9001 standards—the cornerstones of medical device compliance worldwide.
What You'll Gain
In this intensive 10-credit Level 9 programme, you'll develop a comprehensive understanding of quality management systems while building the strategic capabilities needed to navigate the complex post-market landscape. From audit management and regulatory compliance to pricing, reimbursement, and customer complaints handling, you'll master the full spectrum of skills that employers demand in today's regulatory affairs professionals.
Why This Programme Matters
The medical technology sector depends on professionals who can bridge technical compliance with commercial strategy. You'll learn to manage regulatory affairs departments effectively, communicate confidently with regulatory agencies, and advise commercial teams on critical post-market requirements. Real-world case studies and collaborative learning ensure you can apply these skills immediately in your career.
Programme Highlights
Part-time delivery designed for working professionals
Practical focus on CFR 820, ISO 9001 and ISO 13485 quality systems
Strategic insights into post-market surveillance, health technology assessment, and product lifecycle management
Industry-relevant skills in audit hosting, documentation control, and regulatory compliance
Contemporary topics including environmental compliance, packaging regulations, and advertising standards
Who Should Apply
This programme is ideal for professionals working in or aspiring to roles in regulatory affairs, quality assurance, compliance, or medical device management. Whether you're looking to advance in your current role or transition into the regulatory field, this certificate provides the credentials and capabilities to excel.
Applicants require a second class honours degree or higher, or an equivalent in a science, business or management subject. Other applicants will be considered on an individual basis in accordance with the University policy on Recognition of Prior Learning (RPL). SETU reserves the right to require applicants to attend for an interview to determine their suitability for the programme.
This course will contribute 10 credits towards the MSc in Medical Device Regulatory Affairs
Explore our Postgraduate Prospectus to view the full range of postgraduate study options, including course details, entry requirements, and progression routes. Download the prospectus to help you choose the programme that best suits your goals.
