IMed Consultancy provides specialist regulatory and quality support for in vitro diagnostics (IVDs) and companion diagnostics. Whether you’re developing an innovative new product or managing existing devices under evolving in vitro diagnostic regulations, our experts help you achieve and maintain compliance with clarity and confidence.
From early design to post-market monitoring and staying on the market, we make complex regulatory pathways manageable so you can focus on innovation and growth.
Expert IVD Consulting for Every Stage
With over two decades of experience in IVD consulting, IMed Consultancy supports manufacturers, importers, and distributors in meeting global regulatory requirements. Our team brings decades of combined experience, allowing us to anticipate the unique challenges of developing in vitro diagnostics medical devices and guide you through every step from design to documentation.
We help with:
Managing In Vitro Diagnostic Regulations
The in vitro diagnostic regulations in the EU and the US have raised the bar for evidence, safety, and performance. IMed Consultancy’s specialists guide your team through compliance with CE and UKCA marking requirements, as well as FDA expectations. We’ll assess classification, identify gaps, and prepare your submission or technical documentation, giving you a clear roadmap to regulatory approval..
Our IVD consultancy services include training, audits, and document reviews for teams who want expert oversight while retaining internal control.
Companion Diagnostics:
The Future of Personalised Medicine
Companion diagnostic devices play a vital role in precision medicine, matching patients to the right treatments through biomarker analysis. These products are regulated as in vitro diagnostic medical devices, meaning they must meet rigorous safety and performance standards before they reach the market.
IMed Consultancy offers strategic support for companion diagnostics device regulations, helping you align with device and pharmaceutical frameworks. Whether you’re developing a new companion diagnostic or managing compliance for an existing one, we provide the clarity and structure you need to move forward confidently. Our team also supports the generation and coordination of evidence for combined clinical trials under an Investigational New Drug (IND), including documentation for Clinical Trial Applications (CTAs).
Our IVD Consultancy and Companion Diagnostics Expert
Jonathan Ripley
IMed Consultancy’s specialists blend deep regulatory knowledge with real-world commercial insight. We help clients of all sizes, from growing startups to global manufacturers, accelerate innovation while maintaining the highest compliance standards.
Why Work with IMed Consultancy?
Our clients choose IMed for more than expertise. They trust our partnership approach. We act as an extension of your team, offering flexible, scalable regulatory support across all IVD and companion diagnostic categories.
We’re known for:
Frequently Asked Questions
Developing or marketing diagnostic products can feel complicated, especially under the evolving in vitro diagnostic regulations. Here are some of the most common questions clients ask our IVD consultants.
An IVD consultancy provides expert support with product classification, performance evaluation, documentation, and submission. At IMed, we go further, helping you align your regulatory strategy with your commercial goals so both move forward as one.
Our consultants have held senior roles within the MedTech industry, giving them the practical insight to build regulatory pathways that support business success. The result is a unified, strategic approach that accelerates compliance and strengthens your market position.
While companion diagnostics devices are classified as IVDs, they’re also subject to additional oversight due to their role in guiding treatment decisions. IMed helps you interpret and comply with companion diagnostics device regulations across different markets.
Regulation (EU) 2017/746 (IVDR) transitions. We conduct gap analyses, update documentation, and train teams to maintain compliance under the new framework.
Absolutely. IMed supports clients of all sizes, from early-stage innovators developing their first diagnostic product to global manufacturers with extensive portfolios.
Engaging a consultant early (ideally before finalising your design or performance testing plan) can save significant time and cost. Early input ensures alignment with in vitro diagnostic regulations, reduces rework, and helps you avoid costly missteps when generating clinical evidence, often the most resource-intensive stage of development.
Ready to Simplify Diagnostic Compliance?
IMed Consultancy makes IVD and companion diagnostic compliance straightforward. Whether you need help with technical documentation, Regulation (EU) 2017/746 (IVDR) requirements, UK MDR/ 2002 updates, or FDA submissions, our team is ready to help you bring your device to market safely and efficiently.