Healthcare Innovation + Regulatory Consulting
Expert help for your medical device & diagnostics projects
device development with compliance built in as standard
Your development experts
Red Medtech specialises exclusively in one thing: Helping you manage your medical device projects.
At any point in the product lifecycle: from innovation concept to production, certification and post-market support, we provide expert consulting solutions direct to new product developers and manufacturers globally, from our base in Wales, UK.
Built on a passion for pioneering healthcare technology - Helping People Help People™
Red Medtech brings over 20 years of practical first-hand experience in medical device engineering and manufacturing to your projects.
We have been there: designing products, creating inventions, engineering solutions, writing technical specifications, establishing ISO 13485 quality systems, authoring regulatory compliance documentation, and steering project teams.
Now we are here to help you!
Get practical project support
Our extensive medical technology development experience can deliver the help you need with:
- Medical device consultancy and Q&A
- Managing product development projects
- Engineering design for compliance
- Design & development document creation
- Regulatory submissions and audits
- Technical Files for CE marking & UKCA
- EU, UK, & US Medical Device Regulations
- ISO 13485 Quality Management Systems
- Medical Device Single Audit Program
- Legacy MDD to EU MDR device remediation
- UK Responsible Person - UKRP
- PRRC - Person Responsible for Regulatory Compliance for EU MDR/IVDR
And much more - to discuss your project with us:
Helping People Help People™
Red Medtech was founded in West Wales by Professor Laurie Rowe: an award-winning engineer, designer, and serial inventor with extensive and diverse experience working in healthcare technology, development, and manufacturing both in the UK and for international projects.
Find out more about the unique story behind the Red Medtech consulting practice and explore partnership opportunities:
Our Partners, Values & Awards
