Post-Market Surveillance for Radiation Therapy Software
Gerhard Pfaffenzeller
Broschiertes Buch

Post-Market Surveillance for Radiation Therapy Software

How to use Adverse Event and Recall Database Information for Risk Management

Versandkostenfrei!
Versandfertig in 6-10 Tagen
19,99 €
inkl. MwSt.
PAYBACK Punkte
10 °P sammeln!
The study presents cases of accidents that occurred during radiation therapy and discusses associated publicly available post-market surveillance data. Based on this data it recommends how to use post-market surveillance data from adverse event and recall databases for risk management. The ISO 14971 and IEC 62304 standards as well as FDA guidance documents require medical device manufacturers to periodically analyze post-market information about their own and similar devices following their production and software delivery. This post-market information is reviewed as part of the post-productio...