IASON consulting offers tailored solutions for your post market devices in compliance with the MDR 2017/745. Our team of experienced consultants, who are equipped with the necessary knowledge, assists you in Post Market Surveillance (PMS) activities including vigilant reporting to the relevant authorities. A post market package provides necessary documents and reports analysing pertinent data during proactive PMS activities.
As part of the Post Market Package, IASON offers comprehensive Post Market Surveillance (PMS) according to the relevant standards and requirements. This also includes a thorough PMS Plan and Gap Analysis, which is mandatory for low-risk class I devices.
If sufficient PMS data is not available, a Post Market Clinical Follow-up (PMCF) may be required, which can include trials as well as studies for relevant clinical data for a comprehensive clinical evaluation update. This also includes a PMCF Plan.
Crucial to any PMS and PMCF activities is the requirement of vigilant reporting to the relevant authorities. Such reports include PMS reports (PMSRs) for Class I devices, Periodic Safety Update Reports (PSUR) for higher risk devices (Class IIa, IIb, III, IVD device Class C and D), and PMCF reports, which we will happily assist you in.
Want to find out more about our Post Market Package? Get in touch now.