You will develop an understanding of the key stages involved in bringing a medical device from concept to commercialisation. This includes device design and development, design controls, risk management, manufacturing processes, validation and testing methodologies, and quality management systems.
The programme also explores the regulatory frameworks and international standards that govern the medical device industry, including ISO 13485, ISO 10993, IEC 62366 and 21 CFR Part 820. Through industry-based examples and case studies, you will examine how these requirements are applied in practice to support product quality, safety and compliance.
By the end of the programme, you will be able to evaluate the processes, standards and regulatory considerations that influence medical device development throughout the product lifecycle.
Further studies and career opportunities
This programme supports professional development for those working in, or seeking to move into, medical device manufacturing, quality assurance, regulatory affairs, validation, product development and related functions within the life sciences sector.
The knowledge gained is also relevant to professionals responsible for compliance, quality systems and the management of regulated products. As a Level 9 qualification, the programme may also support progression to further postgraduate study in medical technology, quality, regulatory affairs and related disciplines.
You will develop an understanding of the key stages involved in bringing a medical device from concept to commercialisation. This includes device design and development, design controls, risk management, manufacturing processes, validation and testing methodologies, and quality management systems.
The programme also explores the regulatory frameworks and international standards that govern the medical device industry, including ISO 13485, ISO 10993, IEC 62366 and 21 CFR Part 820. Through industry-based examples and case studies, you will examine how these requirements are applied in practice to support product quality, safety and compliance.
By the end of the programme, you will be able to evaluate the processes, standards and regulatory considerations that influence medical device development throughout the product lifecycle.
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. This is a postgraduate course so ideally applicants will have an Honours degree in a cognate area. We can also assess applicants who have significant industry experience as recognition of Prior Learning Applicants (RPL)
This course is part of the MSc in Medical Device Regulatory Affairs. Applicants can consider completing this programme on successful completion of this programme.
Explore our Part-time Prospectus to see the range of flexible study options available, with detailed course information, entry requirements, and study formats. Download the prospectus to find a programme that fits around your work and other commitments.
