Company Background: Red Medtech provides expert technical, regulatory, quality, and project management consulting for medical device developers. With over 20 years of hands-on experience in healthcare technology, engineering and manufacturing, Red Medtech helps clients deliver innovative patient care solutions to market.

Product/Service: Healthcare is a complex, regulated industry, so companies rely on Red Medtech for specialist guidance and practical support. Drawing on extensive professional experience, Red Medtech offers flexible consulting solutions tailored to diverse customer needs - from startups to multinationals. Red Medtech provides engineering compliance expertise supporting healthcare projects from concept to production, certification and post-market.

Expertise: Red Medtech is a trusted partner dedicated to customer success, helping companies navigate the regulatory landscape to develop safe medical devices and achieve certification including ISO 13485, EU MDR CE mark, UKCA, and US FDA.

How we can help: At Red Medtech, we are committed to helping you navigate the complex world of regulatory compliance with ease. Our expertise and tailored support will assist you in the following ways:

Specialist Support: Whether you need temporary remote assistance, complete project outsourcing, or MDD-MDR transition and remediation support, we can help. We work closely with you to understand your needs and develop a customized solution that fits your budget and timeline.

Projects: If your team needs additional capacity and/or expertise for specific tasks, we offer project-based support. Our services include project appraisals, regulatory, quality and development strategy, gap analysis, design history file creation, technical files, and much more. With full cost and deliverable transparency, you'll know exactly what to expect.

Subscription Monthly Retainers: For ongoing regular support, our monthly retainer is the perfect solution. Gain access to highly experienced specialist consultants who can answer your questions, manage projects, and complete tasks according to your needs. We offer flexible options, from a few hours per month to a number of days each week, so you can choose what works best for you.

Quality System Management: Implementing and maintaining compliance can be challenging. With industry expertise and experienced Notified Body trained Lead Auditor in-house, we can help you stay on track, identify areas of improvement, and address issues proactively, avoiding potential audit problems. Additionally, our Quality, Regulatory and Project Leadership technical professional can act as your QA/RA/PM function on a temporary, regular, or long-term basis, providing you with extra support to maintain your QMS.

Partner with Red Medtech and let us help you achieve regulatory compliance with confidence.

Contact us now to discuss your regulatory compliance needs.