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Specialists in SaMD, IVDs, and diagnostics
Experienced team with regulatory and quality assurance backgrounds
Trusted by growing startups and global manufacturers

Regulatory Expertise Across Every MedTech Product Type

IMed Consultancy’s regulatory and quality experts support MedTech advancement across the full product spectrum, from high-risk implants to next-generation digital health technologies. We provide tailored regulatory consulting for medical devices, in-vitro diagnostics (IVDs) and companion diagnostics, software as a medical device (SaMD) and AI-enabled digital health, combination products, and borderline products.

Whatever you’re developing, our team gives you the clarity, confidence, and compliance needed to move from concept to market (and stay there) safely and efficiently.

Book a Call with a Regularity Expert
The logo for ABHI (Association of British HealthTech Industries) features the acronym in a clean, minimalist, all-caps sans-serif typeface. The letters are rendered in a professional slate-blue color. The design is notable for its geometric styling, particularly the "A," which lacks a traditional horizontal crossbar, and the "B," which is formed with distinct, open curves. This modern aesthetic reflects a forward-thinking and technical industry focus.
The BIVDA Member badge for 2022 features a circular seal design rendered in a muted slate-blue. In the center, a solid rectangular block with a slanted right edge contains the acronym "BIVDA" in large, white, sans-serif capital letters. The word "MEMBER" arches along the top of the circle in a matching blue font, while the year "2022" curves along the bottom. Thin circular lines frame the text at the top and bottom, completing the professional, official look of the membership emblem.
The logo for ISO 13485 features a central globe icon composed of blue-gray longitude and latitude lines on a black background. Superimposed over the center of the globe is the word "ISO" in a heavy, bold, blue-gray sans-serif font. Arching around the top of the globe is the full name, "International Organization for Standardization." Below the globe, the specific standard number "13485" is displayed in bold, followed by the descriptive text "Quality Management System" in a cleaner, lighter typeface. All elements are rendered in a consistent muted blue-gray color.
The logo for Medilink Midlands features a large, stylized "M" icon rendered in a slate-blue color. The icon has a smooth, fluid shape with rounded peaks and a soft wave at the bottom, giving it a modern and professional feel. Below the icon, the company name is stacked in two lines of all-caps, sans-serif text in the same slate-blue. "MEDILINK" appears on the top line, with "MIDLANDS" centered directly beneath it, utilizing a clean and balanced typeface.
A circular badge for "The Hill NHS Market Access Accelerator" featuring a stylized skyline and heartbeat line graphic, with a "Partner" banner at the bottom.
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Medical Devices

From concept to market approval across the UK, EU, and US, IMed Consultancy helps you bring safe, effective medical devices to market with clarity and speed. Our team supports every stage of the regulatory process from classification and technical documentation to post-market surveillance and remediation. Whether you are preparing your first 510(k) or MDR / IVDR submission, managing a global portfolio or navigating post market requirements, we’ll guide you through every compliance milestone with precision and confidence.

Get your medical device market-ready

In-Vitro Diagnostics and Companion Diagnostics (CDx)

Diagnostics are evolving fast, and so are the regulations. IMed Consultancy’s IVD specialists bring deep technical and regulatory expertise to help you meet US FDA and IVDR requirements, generate performance data, and maintain compliance post-launch. We also support companion diagnostics (CDx), bridging the gap between pharma and MedTech to help you meet regulatory and clinical expectations.

Accelerate your IVD approval path
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Software as a Medical Device (SaMD) and AI-Enabled Digital Health

Regulating digital health demands precision and agility. IMed Consultancy helps you manage SaMD and AI/ML requirements, from IEC 62304, cybersecurity ISO 81001-5, from clinical evaluation to usability IEC 62366-1. Our consultants translate complex frameworks into clear, actionable steps so you can move fast and stay compliant in a rapidly shifting digital health landscape.

Turn your code into a compliant device

Combination Products

When your product blends device, drug, or biologic components, classification and regulation become complex. IMed Consultancy provides integrated guidance on global combination product frameworks, aligning device and pharmaceutical requirements to accelerate your route to market. From documentation to submission strategy, we ensure every component meets the highest compliance standards.

Simplify your combination product strategy
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Borderline Products

If your product sits in the grey area between categories, IMed Consultancy helps you define the right regulatory pathway. Our team assesses classification, intended use, and technical evidence to guide you toward the correct designation, whether device, cosmetic, or medicinal. With clear documentation and regulator-ready rationale, we remove uncertainty and get your product moving.

Get clarity on your product classification

Why IMed Consultancy?

Since 2012, IMed Consultancy has supported MedTech innovators, QA/RA leaders, and global manufacturers in achieving regulatory success. Our specialists combine technical depth with real-world commercial understanding, providing a partnership that feels like an extension of your own team.

Talk to a regulatory expert today