Our Services
Why Choose Nexus QR?
At Nexus QR, we understand that navigating regulatory pathways can be complex, especially in the rapidly evolving field of digital health. That’s why we prioritize efficiency, precision, and collaboration to make your journey straightforward.
Our goal is to be more than just a service provider—we aim to be a dedicated partner who understands your unique needs and supports you every step of the way.
Here’s why companies choose Nexus QR:
Specialized expertise in digital health.
Transparent communication at every step.
Comprehensive UKRP services.
Fast, accurate documentation review.
Seamless MHRA submission process.
Tailored strategies for each client.
Ongoing post-market compliance support.
Proven track record of success.
Our Process
Our streamlined approach ensures your product meets UK compliance requirements quickly, so you can focus on delivering groundbreaking health solutions without regulatory delays.
Classification and Strategy
We assess your product’s risk class and develop a tailored regulatory plan, aligning with UK standards to ensure a smooth, efficient compliance pathway.
Documentation and Submission
Our team reviews technical documents thoroughly, preparing and submitting a precise, compliant application to the MHRA while managing any follow-up queries for swift approval.
Ongoing Compliance Support
Post-registration, we oversee required surveillance, updates, and modifications to keep your product fully compliant throughout its lifecycle within the evolving UK market landscape.
UKRP Registration Services
We handle complete MHRA registration processes to ensure swift UK market access.
Technical Documentation
We review, organize, and maintain all required documentation for continuous regulatory compliance.
Post-Market Surveillance
We monitor product performance and manage ongoing compliance requirements in the UK.
Device Classification Support
We determine your product’s risk classification and establish specific regulatory requirements.
MHRA Submission
We handle the entire submission process, managing MHRA communications for approval.
Strategy Development
We create tailored compliance regulatory strategies for digital health and AI technologies.
Frequently asked questions
What is a UKRP?
A UK Responsible Person (UKRP) acts as your official representative within the UK market, handling MHRA registration, maintaining technical documentation, and ensuring ongoing compliance with all regulatory requirements.
Do I need a UKRP?
If you’re a non-UK manufacturer planning to place medical devices, including software and AI solutions, in the UK market, you legally require a UKRP to handle all regulatory obligations and communications.
What documents do I need?
You’ll need technical documentation, Declaration of Conformity, clinical evaluations, risk assessments, and quality management system documentation. We’ll guide you through all specific requirements for your device category.
Do you handle software and AI devices?
Yes, we specialize in Software as Medical Device (SaMD) and AI-based healthcare solutions. We understand the unique regulatory requirements and compliance needs for digital health technologies in detail.
What happens after registration?
We continue monitoring compliance, handle post-market surveillance, maintain documentation, manage MHRA communications, and ensure your product meets all ongoing regulatory requirements in the UK market system.