Services
We provide comprehensive UKRP services to help medical device manufacturers enter the UK market.
UKRP?
Are you a non-UK manufacturer looking to place medical devices on the UK market? If so, you’ll need a UK Responsible Person (UKRP).
UKCA Certification?
Are you a non-UK manufacturer looking to place medical devices on the UK market? If so, you’ll need UKCA Certification
Quality & Regulatory Consultation?
Are you looking for any Quality & Regulatory Support?
About
At Nexus QR, we are at the forefront of empowering transformative health technologies to thrive in the UK market. Specializing in Software as a Medical Device (SaMD) and digital health solutions—including AI and machine learning-driven applications.
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.