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Research & Impact
A Quality Management System (QMS) is a formalised system that documents processes, procedures, and responsibilities for achieving quality products. It helps coordinate and direct an organisation’s activities to meet customer and regulatory requirements. In doing so, the quality management system, as a framework, creates consistent and documented processes throughout a product’s lifecycle, and supports adherence to the necessary regulations and standards.
The School of Biomedical Engineering & Imaging Sciences offers a Quality Management System (QMS) and bespoke regulatory support for medical device development. We support projects with their technical file creation and adherence to medical device regulatory requirements.
We offer three work packages for Design and Development depending on the objectives of the project, and a manufacturing work package for the Manufacture of Active Implants and Surgical Instruments (MAISI).
QMS support typically starts with induction training, and involves fortnightly meetings with the project team to guide you through completing your documentation and discuss overall strategy. In addition to the regular QMS meetings, we work with projects during Design Reviews and Risk Assessments.
Recommended for all medical device design projects.
Quality Team support: low
Recommended for basic science and HIE clinical studies.
Quality Team support: medium
Recommended for all projects that will require MHRA review i.e. clinical investigations or CE/UKCA marking.
Quality Team support: High
Recommended for all projects manufacturing clinical prototypes using the organisational facilities e.g. MAISI
For help with any questions on processes and regulations to design and produce your device for clinical translation we offer Medical Engineering Quality and Regulatory Drop-In sessions fortnightly on Wednesdays from 2-3pm.
For upcomng session dates and more information, please email: email@example.com