Founded by a practising Head of QA&RA with 10+ years across MD, IVD, and SaMD — Nexus QR gives non-UK manufacturers direct access to an expert who does this work every day.
From MHRA registration to ongoing compliance — we handle the regulatory heavy lifting so you can focus on building your device.
We act as your MHRA-registered UK presence for MD, IVD, and SaMD — handling device registration, post-market obligations, and incident reporting on your behalf.
Deep specialist knowledge in Software as a Medical Device, AI/ML devices, and in vitro diagnostics — including IEC 62304 software lifecycle and UK IVDR pathway advisory.
From QMS design and ISO 13485 implementation to CAPA management and EU MDR alignment — the regulatory backbone your product needs from day one.
No complexity theatre. A focused, three-step process from first call to full compliance — with a specialist by your side throughout.
We assess your device type (MD, IVD, or SaMD), risk classification, and regulatory pathway — then map a tailored UK compliance strategy from day one.
We register your device on MHRA DORS, manage your submission, handle technical file review, and respond to any MHRA queries on your behalf.
Post-registration, we manage your ongoing UKRP obligations — PMS, vigilance reporting, change notifications — so compliance never becomes a bottleneck.
Our founder is a working Head of QA&RA — actively navigating the same regulatory landscape your device faces. You get real, current expertise, not templated advice.
MD, IVD, SaMD — including AI/ML products and connected diagnostics. No handoffs, no subcontracting. One expert who understands the full spectrum.
When you work with Nexus QR, you work directly with Nischith Raphael — MHRA-registered UKRP, Lead Auditor, and ABHI member. No account managers. No junior proxies.
Regulatory complexity shouldn't be the reason a life-changing device doesn't reach patients. Nexus QR removes that obstacle — with genuine expertise, not generalism.
Nischith Raphael is a medical device regulatory professional with over 10 years of hands-on experience across conventional medical devices, in vitro diagnostics, and Software as a Medical Device. He currently works as Head of Quality Assurance and Regulatory Affairs — meaning the advice you receive from Nexus QR is grounded in real, active regulatory practice, not theory.
Nischith has led QMS implementations from the ground up, achieving ISO 13485 and MDSAP certification in under a year with zero major non-conformances, across multi-jurisdictional registrations covering the UK, EU, UAE, and Asia-Pacific. His IVD and SaMD work spans AI-driven health tools, connected diagnostics, and clinical decision support software.
He is a Lead Auditor to ISO 13485:2016, a contributor to IEC 62304 software lifecycle process development, and a member of the Association of British HealthTech Industries (ABHI). He holds an MSc in Aerospace Materials from the University of Sheffield — a background that brings rigorous engineering thinking to every regulatory challenge.
Nexus QR was founded to give non-UK manufacturers direct, affordable access to the level of expertise typically locked inside large organisations — with full transparency, clear timelines, and no unnecessary complexity.
Specialist services for medical device, IVD, and SaMD manufacturers entering or maintaining the UK market. No generalism — just the work that moves the needle.
Under UK MDR 2002, non-UK manufacturers must appoint a UK Responsible Person to register their devices with the MHRA. Nexus QR acts as your UKRP — MHRA-registered, managing your UK compliance obligations for conventional medical devices, IVDs, and SaMD, and ensuring your products remain on the market without disruption.
Software as a Medical Device, AI/ML-driven health tools, and in vitro diagnostics require a level of regulatory depth that generalist consultants often cannot provide. Nexus QR brings direct hands-on experience in each of these categories — from early classification through to market authorisation and post-market obligations.
From QMS design to CAPA management, EU MDR alignment, and long-term regulatory strategy — we work as a flexible extension of your team, with the depth to handle complex submissions and the speed to keep your timelines on track.
UKCA certification requirements are currently in a period of regulatory flux, with the MHRA continuing to accept CE marking for many device categories. We provide pragmatic, up-to-date advisory on your UKCA obligations — so you can plan ahead without over-investing in a moving target.
Practical, practitioner-written takes on UK MedTech regulation, MHRA updates, and what they mean for your product.
A plain-English walkthrough of MHRA DORS registration for non-UK manufacturers — from appointing a UKRP to your first approved listing.
Not every health app is a medical device — but if yours makes a clinical claim or drives a clinical decision, it almost certainly is. Here's how to tell.
The UK's IVD framework diverged from the EU IVDR after Brexit. If you're bringing a diagnostic to the UK market, here's what you need to know now.
Build your technical file and QMS with both markets in mind from day one — and avoid the costly rework of treating them as entirely separate projects.
Whether you're starting from scratch or picking up a stalled submission — we'll give you a straight answer about where you stand and what it takes to get there.
Thank you — Nischith will be in touch within 24 hours.