IVDeology partners with international medical device and diagnostic companies to accelerate market access and ensure regulatory compliance across the UK, EU, USA and other global territories.
Our highly qualified experts can fully support your quality and regulatory product journey with our four service pillars of Build, Accelerate, Outsource and Maintain providing you with the key foundations for a successful QARA strategy.
Welcome to IVDeology
IVDeology is your Trusted Partner in IVD Compliance and Quality Assurance.
In vitro diagnostics (IVDs) play a crucial role in healthcare by enabling early detection, accurate diagnosis, and effective monitoring of diseases, which ultimately leads to better patient outcomes. The design and development of IVDs are critical to ensure their safety, reliability, and compliance with regulatory standards, ensuring they provide accurate and consistent results and improve quality of life.
Our expert team offers comprehensive consultancy services to ensure your IVD products meet the regulatory requirements and quality standards across global markets, including supporting non-UK companies get onto the UK market.
Build
IVDeology partners with you to build your Regulatory Strategy, Quality Management System and Technical Documentation, ensuring you meet your key objectives and project timelines whilst also establishing your company-wide Quality Culture.
Accelerate
Accelerate your route to market by utilising IVDeology’s experts as an extension to your technical team. Together we will navigate the regulatory pathway efficiently and cost-effectively, inclusive of upskilling & in-house training options for your team.
Outsource
Fully or partially outsource your quality/regulatory requirements, utilising IVDeology’s expert team and robust QMS. From PRRC, UKRP and EUAR to other global territories, along with CDMO/CRO solutions from our parent company, Abingdon Health.
Maintain
Regulatory compliance never stops and as your trusted knowledge partner, the IVDeology team can continue to support your product compliance with Quality Audits, QMS Health Checks, Post-Market Surveillance and Regulatory Intelligence.
Get In Touch To Discuss Your Project
Book a meeting with a member of the IVDeology team
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