Sterile Management Systems Ltd are proud to offer UKRP service globally to Medical Device & IVD manufacturers.
Selecting a UKRP is entirely the manufacturer’s choice. Naturally, you will want to work with a trusted partner who will responsibly represent you with the UK authorities. Sterile Management Systems team collectively have 100+ years Medical Device and regulatory experience meaning we are perfectly placed to help.
Benefits of selecting S.M.S as your UKRP Partner
Registration with MHRA
The UKRP is responsible for ensuring that Medical Devices / IVD Devices entering the UK market are fully registered with the UK Competent Authority, Our team will carry this out and maintain on your behalf
Provide relevant info to MHRA
The UK Competent Authority requires that the UKRP retains / has immediate access to the Technical Documentation pertaining to each registered device. S.M.S will hold copies on our secure file server, where requested we will act liaise with the MHRA directly
Keep you informed of any Complaints or Incidents
As the registered and published UK Representative for your product, Health Authorities and the public may contact us about an issue with your device, in these cases we will ensure you are informed and assist you with any resulting actions
Professional yet Affordable
We pride ourselves in service and fairness. We are genuinely interested in helping you and your business achieve its global reach, in turn helping more patients gain access to the best and latest medical technologies.
We believe this should not be prohibited by cost