Example: stock market
Psur
Found 2 free book(s)MDR Conformity Assessment Routes - BSI Group
www.bsigroup.comSampling Plan or at the time of PSUR assessments Post Market Clinical Follow-Up Update Report (Article 61) Updated at least annually; NB to review as per Technical Documentation Sampling Plan or at the time of PSUR assessments Periodic Safety Update Report (Article 86) Updated when necessary and at least every two years;
ICH guideline E2F on development safety update report
www.ema.europa.euBoth the DSUR and PSUR should be comprehensive and stand alone as they focus on different subject matter and have differing periodicities and recipients. 1.5. Recipients of the DSUR . The DSUR is intended to serve as an annual report to regulatory authorities. Where …