RED MEDTECH
Red Medtech is a medical device consultancy based in Wales, UK, specializing in helping clients manage their medical device projects throughout the product lifecycle. With over 20 years of experience, they provide expert consulting in product development, regulatory compliance, quality management systems, and technical documentation. Their mission is to support innovators, designers, and manufacturers in delivering safe and effective healthcare products to market, with a focus on compliance and regulatory standards such as ISO 13485, EU MDR, UKCA, and US FDA regulations. They serve a wide range of clients from startups to large organizations, offering tailored solutions to meet specific project needs.
Industries
Nr. of Employees
small (1-50)
RED MEDTECH
Swansea, Swansea, United Kingdom, Europe
Services
Support for regulatory strategy, conformity pathways, liaison with regulators and provision of qualified Persons Responsible for Regulatory Compliance (PRRC) and UK Responsible Person roles.
Implementation, update and harmonisation of ISO 13485 quality management systems, internal and supplier auditing, and MDSAP support.
End-to-end product development support including engineering design for compliance, documentation (DHF, technical files), risk management and usability inputs from concept through to production.
Tailored project management, steering, coordination and stakeholder communications to deliver product development and compliance programmes.
Management of international production line transfers, production quality engineering for scale-up and supplier/site harmonisation to support volume manufacture.
Planning and execution of usability studies and human factors engineering activities to meet IEC 62366-1 and support device validation.
Support for regulatory strategy, conformity pathways, liaison with regulators and provision of qualified Persons Responsible for Regulatory Compliance (PRRC) and UK Responsible Person roles.
Implementation, update and harmonisation of ISO 13485 quality management systems, internal and supplier auditing, and MDSAP support.
End-to-end product development support including engineering design for compliance, documentation (DHF, technical files), risk management and usability inputs from concept through to production.
Tailored project management, steering, coordination and stakeholder communications to deliver product development and compliance programmes.
Management of international production line transfers, production quality engineering for scale-up and supplier/site harmonisation to support volume manufacture.
Planning and execution of usability studies and human factors engineering activities to meet IEC 62366-1 and support device validation.
Expertise Areas
- Medical device regulatory compliance (EU/UK/US)
- Design History File (DHF) and Technical File authoring
- ISO 13485 quality management systems and auditing
- New product development (NPD) and design for compliance
Key Technologies
- ISO 13485 quality management systems
- IEC 62304 medical device software lifecycle
- IEC 60601 electrical safety for medical equipment
- ISO 14971 risk management
News & Updates
Red Medtech will be exhibiting at the Med-Tech Innovation Expo 2025 on June 4–5 at NEC Birmingham, showcasing their medical device consulting services and sharing insights on development compliance.
Top Medical Device Consultant Winner 2024
Recognition as a leading consultancy in the medical device industry for 2024.
Medical Device Specialists of the Year 2024
Awarded for excellence in medical device consulting in 2024.
Medical Device Innovators of the Year 2023
Honored for innovation in medical device development in 2023.
Red Medtech will be exhibiting at the Med-Tech Innovation Expo 2025 on June 4–5 at NEC Birmingham, showcasing their medical device consulting services and sharing insights on development compliance.
Top Medical Device Consultant Winner 2024
Recognition as a leading consultancy in the medical device industry for 2024.
Medical Device Specialists of the Year 2024
Awarded for excellence in medical device consulting in 2024.
Medical Device Innovators of the Year 2023
Honored for innovation in medical device development in 2023.