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Description
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\n\nEngineers are dedicated to making things work\, so
a focus on how they might fail and harm someone can seem alien.
\n\nManaging risk\, however\, is essentia
l for all medical products- medical devices\, including those involving so
ftware\, have produced some painful examples of poor risk management with
serious consequences. Experience has shown that there is a better way\, th
at it is possible to manage risk in a changing business and technical worl
d.
\n\nRegulatory bodies are pl
acing increased emphasis on risk management\, and technology shifts are in
troducing new sources of risk. Newer Lean-Agile methods are recognized by
the FDA as a good way to accomplish risk management.
\n\nTechniques for risk management are well establis
hed\, but require specific interpretation when applied to software. In thi
s session\, we will show a way of knitting risk management into the develo
pment process\, so that it is integral to product development\, not a ten
ton caboose dragging the train back down the mountain.
\n\n
\nWhy you should attend:
\n\
nPerhaps your engineering team is beginni
ng its transition to an Agile approach - or perhaps you have a seasoned Ag
ile team and you'\;re just beginning work on FDA-regulated products. Yo
u know that risk management is required\, but it'\;s not at all clear h
ow you should address it as you go through your backlog grooming\, iterati
ons\, and end-user demonstrations. The process in ISO 14971 seems "\;l
inear"\; and unsuited to a highly iterative\, dynamic lifecycle. How c
an you fit it into your approach?
\n\n
\nAreas Covered in the Session:
\n\n\n Software has introduced (or been blamed for) s
ome serious safety hazards \n - All medical device standards intersect on the topic of risk management
\n - Risk analysis starts with th
e intended use statement
\n - R
isk information is available from multipl sources - use them!
\
n - Note that safety is an emergent proper
ty
\n - Changes are often the b
iggest sources of risk
\n - Don
'\;t ignore the human factors side\; understanding your users is crucia
l to safety
\n - Applying engin
eering risk methods to software requires us to translate some concepts
\n - Though standards draw a roadm
ap for risk management\, WE must figure out the route
\n Risks often arise when we add new features - s
o incremental risk management is the most effective \n - Forget the notion that "\;software can'\;
t hurt anyone"\;
\n - Never
conduct risk analysis by using a checklist from 14971
\n - <
span style="color:#000000\;">Exploding technology brings numerous chances
for risk to multiply
\n
\n\n
\nWho will benefit:
\n\n\n - Project managers
\n - Regulatory specialists
\n - Q
uality assurance specialists
\n - Documentation specialists
\n - Test managers
\n - Software
team leaders and lead developers
\n
\n
\n \;
SUMMARY:Medical Device Software: An Incremental Approach to Risk and Qualit
y Manage...
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SUMMARY:Medical Device Software: An Incremental Approach to Risk and Qualit
y Manage...
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