Quality and Regulatory Services

Our Mission

Our mission is to assist teams engaged in medical device development by reducing the barriers to clinical translation. We achieve this by promoting the value of quality management and awareness of regulatory requirements at all stages, from device design to the development and clinical evaluation of product prototypes. We advocate for a flexible and highly configurable approach based on project objectives and available resources.

Our Services

We offer cost-effective and specialized resources to meet regulatory requirements and support commercialisation. Our services include:

• Quality Management System (QMS) templates: Access to ISO-compliant QMS templates, including example processes, procedures, guidance documents, and technical file templates.
• Electronic Document Management System (eDMS): Dedicated project space in Cognidox, a lean and configurable eDMS.
• Example Technical File Documents: Templates and examples to streamline your documentation process.
• Specialized Personnel Training: Medical device regulations, standards, and quality management training.
• Expertise in medical device regulations and standards: Guidance on device qualification, classification, regulatory requirements and medical device standards.
• Specialist Advice on AI-based Technologies and Software as a Medical Device: Tailored advice for cutting-edge technologies.

Who Can Access These Services?

Our services are available to UCL staff and students involved in medical device development, including medical software that must meet NHS Digital Health IT Systems standards. We also welcome external clients, particularly university spinouts and MedTech start-ups developing commercial medical devices or digital technology healthcare products. 

Importance of Medical Device Standards & Regulations

All medical devices must adhere to relevant regulations before being used on patients, whether in clinical investigations or when placed on the market. A clear understanding of these regulatory requirements is essential for compliance and to support your overall business strategy. Early engagement with regulatory requirements can help identify key barriers to commercialisation and clinical deployment. Operating within a Quality Management System (QMS) helps to provide the necessary evidence of regulatory conformity and will ensure that your product meets essential safety and performance standards.

Contact MedicalDeviceEngineering@UCL.ac.uk for more information