Risk/hazard analysis for medical devices and their software require extensive analysis, documentation, and maintenance of complex information. Creation and maintenance of extensive tables, fault tree, and HAZOP diagrams can seem overwhelming. For complex and high risk systems the information can be voluminous and software tools can be very productive. Trace tools such as DOORS, CALIBER-RM,...Read More
FDA and 62304 Training – Boston – June 4-6, 2019
3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well. John F. Murray, Jr., will be among the faculty!