We focus exclusively on medical devices, working with micro start-ups and SMEs to large international organizations - so whatever your size, we are here for you:
For more information about how we work:
Here at Red Medtech we specialise in innovative healthcare technology and new medical device development projects.
We can support you from concept to launch and beyond.
Our technical 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:
Our experienced management consulting and implementation services are fully tailored to meet your specific business objectives.
Red Medtech can provide expert medical device project leadership and program management support including: planning and coordination, driving timelines to meet goals, improving communications and team dynamics, providing stakeholder updates and executive progress reporting.
We provide support for your product development, regulatory, and quality projects, either as individual assignments or as part of a larger programme of work, according to your needs.
Red Medtech provide QMS support from updates and improvements for individual procedures and work instructions, through to help implementing new eQMS solutions, including Global franchise integration and harmonization projects across multiple sites.
We can deliver consulting focussed on one or multiple areas of your Quality Management System; from Design Control to Post Market, complaints and CAPA.
With experienced Notified Body trained Lead Auditor in-house, we can support your internal, external, and supplier auditing for ISO 13485 and compliance with MDSAP - Medical Devices Single Audit Program.
Red Medtech are here to help manage and support your international Regulatory Affairs compliance projects for UK, EU, USA and international markets.
Our experienced consulting provides assistance in achieving and maintaining CE mark certification, UKCA mark, FDA 510k clearances and PMA approvals.
We are specialists in transitioning from the EU MDD - Medical Device Directive to the MDR - Medical Device Regulations and supporting every aspect of your Technical File and product DHF - Design History File creation and remediation for CE marking.
Red Medtech Ltd.
C/O Bevan Buckland Llp, Cardigan House, Castle Court Swansea Enterprise park, SA7 9LA
Copyright © 2021 RED MEDTECH ltd - All Rights Reserved.
Red Medtech Ltd. is a company registered in England & Wales with company number 13474362 - VAT Registration Number 426485577.