How we can help
We focus exclusively on managing your medical device projects, working with micro start-ups and SMEs to large international organizations - so whatever your size, we are here for you:
- Trusted medical device expertise
- Product & development compliance
- UK Responsible Person (UKRP) and EU MDR/IVDR Person Responsible for Regulatory Compliance (PRRC)
- Liaising with regulators, Approved & Notified Bodies
- Delivering successful projects
For more information about how we work:
Product Development
Here at Red Medtech we specialise in supporting innovative healthcare technology and new medical device development projects. It's both our background and our passion.
We can help you from concept to market launch and beyond.
Our technical New Product Development (NPD) expertise covers a wide range of device categories, types and classifications including surgical products, instrumentation, drug delivery, critical care, implants, active devices, advanced wound care and patient support equipment, to name a few.
Check out our portfolio page for more product examples:
Project Guidance
Our experienced management consulting and implementation services in the healthcare technology sector are fully tailored to meet your specific business goals and objectives.
Red Medtech can provide expert medical device project guidance and program management support, including planning and coordination; steering activities to meet goals; improving communications and team dynamics; and delivering stakeholder updates and executive progress reports.
We offer support for your product development, regulatory, and quality projects, whether as stand-alone assignments or integrated into a larger programme of work, according to your needs. Let's discuss how we can tailor our services to support your project's unique requirements:
Quality ISO 13485
Red Medtech provides QMS project support, ranging from updates and improvements for individual procedures and work instructions, to implementing new eQMS solutions. This includes solutions for spin-outs through to global franchise integration and harmonization across multiple production sites.
We can deliver consulting focussed on one or several areas of your Quality Management System; from Design Control to Post Market, including complaints and CAPA processes.
With experienced Notified Body trained Lead Auditor in-house, we are equipped to support your internal, external, and supplier auditing needs for ISO 13485 certification and compliance with the Medical Devices Single Audit Program - MDSAP.
Regulatory Compliance
Red Medtech are here to help manage and support your international Regulatory Affairs compliance projects for UK, EU, USA and other international markets.
Our experienced consulting team provides assistance in achieving and maintaining CE mark certification, UKCA mark, FDA 510(k) clearances, and PMA approvals.
We are specialists in transitioning from the EU Medical Device Directive (MDD) to the Medical Device Regulations (MDR) and support every aspect of your Technical File and product Design History File (DHF) creation and remediation for CE marking.
