Medical Device Development + Compliance Consulting

At Red Medtech, we provide expert support for medical devices and diagnostics from concept to production, certification, and post-market activities in the highly regulated healthcare sector. 

Our services include project support for:

• Design & Development Files and Technical Documentation
• Class I to III Devices, Implants, and IVDs
• UKCA, EU MDR CE Mark, and US FDA submissions
• ISO 13485 Quality Management Systems
• Production transfer, scale up, and post-market activities
• Whole product development lifecycle

Founded in Wales, UK, by a design engineer and serial inventor with over 20 years of practical experience in medical technology innovation, engineering, and manufacturing, Red Medtech is dedicated to helping you navigate the complexities of medical device development - with compliance built in as standard.

Red Medtech: Helping People Help People™