Our Blog

Medical Device Field Safety Corrective Actions

Medical Device Field Safety Corrective Actions

EU lay of the land  Medical devices, like all products can potentially go wrong. Robust processes are usually in place at manufacturing organisations to help prevent safety problems, but even the best designed product can be found later to have unexpected design or...

Have you appointed the right UKRP? Part 3

Have you appointed the right UKRP? Part 3

This is the 3rd article in a 3 day, 3-part series which considers some of the upcoming changes to the UK devices regulations and the implications on the UKRP legal service. 1.    Agreements Response to Consultation, 12.2, The changes to the UK Regulations will require...

Have you appointed the right UKRP? Part 2

Have you appointed the right UKRP? Part 2

If you are currently providing a UKRP service or if you are an Ex-UK Medical Device or IVD manufacturer who requires the services of a UKRP, you should consider the following information very carefully. This is the 2nd article in a 3 day, 3-part series which considers...

Have you appointed the right UKRP? – Part 1

Have you appointed the right UKRP? – Part 1

If you are currently providing a UKRP service or if you are an Ex-UK Medical Device or IVD manufacturer who requires the services of a UKRP, you should consider the following information very carefully. This is the 1st article in a 3-day, 3-part series which considers...