Device Quality Limited

Device Quality Ltd. is a quality and compliance consultancy working with clients across the medical device industry. We excel in the development of ISO 13485:2016 / FDA / MDR 2017/745-compliant risk-based QMS processes following extensive stakeholder consultation and alignment. Our technical expertise in implantable active medical devices and structural heart devices allows us to deliver real results for our clients in • new product development and transfer to manufacturing • change controls • design controls and quality assurance • internal audit programmes and CAPA ownership • supplier quality management We have worked with clinical-phase start-ups and multinational medical device manufacturers and we know how to deliver solutions tailored to your business needs. We can help you meet you meet your product testing needs including hardware / software failure analysis and product compliance testing, including • standards analysis (e.g. 60601-1, 60601-1-2) • test strategy development • interactions with external test facilities • test protocol and test report authoring • technical file generation for Radio Equipment Directive (2014/53/EU) compliance