Date :
Place : United States, Baltimore, md
Contact Person:Eevnt Manager
Description:
Engineers are dedicated to making things work, so a focus on how they might fail and harm someone can seem alien. Managing risk, however, is essential for all medical products- medical devices, including those involving software, have produced some painful examples of poor risk management with serious consequences. Experience has shown that there is a better way, that it is possible to manage risk in a changing business and technical world. Regulatory bodies are placing increased emphasis on risk management, and technology shifts are introducing new sources of risk. Newer Lean-Agile methods are recognized by the FDA as a goodDeadline for abstracts/proposals : 1st November 2017
Organized By :NetZealous DBA as GlobalCompliancePanel
Keynote Speakers : Brian Shoemaker consults for healthcare products companies on computer system validation, software quality assurance, and electronic records and signatures. He has conducted validation both on product software and on internal software, developed software quality systems, audited software quality processes (including agile methodology), and evaluated 21 CFR Part 11 compliance. He has had clients in clinical diagnostics, medical device engineering, medical imaging, medical-device fabrics manufactu
Conference Highlights :Project managers Regulatory specialists Quality assurance specialists Documentation specialists Test managers Software team leaders and lead developers
Venue :Baltimore, MD, United States
Check the event website for more details.