Uovo Medtech

We help medical device and IVD businesses get products to market through regulatory, quality and product development support. We have a deep understanding of UK, EU and US regulatory requirements and have in-depth knowledge of the new EU MDR/IVDR (Medical Device Regulation/In Vitro Diagnostics Regulation) and a successful track record of its application. We assist a wide spectrum of businesses but can offer specialist support where medical devices are software intensive or are ‘software as a medical device’, stand-alone software, mobile, cloud and connected devices and digital health systems. We are specialists in software development and the efficient application of relevant standards such as EN 62304 (Medical Device Software Lifecycles), IEC 82304 (Healthcare Software) and the application of ISO 14971 (Risk Management) to complex systems and software. We have in-depth knowledge of information security and the application of ISO 27001 (Information Security Management Systems). We also have extensive knowledge of the development and implementation of bespoke Quality Management Systems (ISO 13485) and the application of quality management principles to software development. Our services: • MDR and IVDR support, such as gap analysis and Technical File and Quality Management System creation and remediation. • Regulatory Strategy • CE Mark Applications and Notified Body liaison • US FDA Submissions • Quality Management Systems to ISO 13485 • Supporting SOPs for Design Control, Software Development, Risk Management, Usability Engineering, etc. • Creation and assessment of Clinical Evaluation Reports • Assessment of Software Capability Maturity and Process Improvement • Design Reviews and Compliance Assessments • Audit preparation and mock audits • Independent Verification and Validation • Safety Critical Systems Engineering • Software Development • Concept and Feasibility Studies Our clients range from start-ups from leading universities to established businesses.