Emblation Ltd

Emblation provides end-to-end medical device development and manufacturing services for innovators including seed funded startups, scale ups, and global industry leaders. Our proven expertise stems from international success of proprietary Swift and SwiftPro microwave devices, supported by an extensive IP portfolio in precision high frequency energy delivery and sensing. We manage the full product lifecycle from concept to production for active medical devices. Our unique value lies in our vertically integrated capability including product design, usability, complex electronics, and safety critical embedded software compliant with IEC 60601, IEC 62304 and cybersecurity regulations. Positioned at the forefront of Scottish medical engineering, we bridge the gap between R&D and production by navigating international regulatory standards. Operating under a rigorous ISO 13485 Quality Management System with ISO 14971 Risk Management, we ensure the delivery of fully compliant device Design History Files (DHF) for global partners.