Course "Medical Device Software: An Incremental
Approach to Risk and Quality Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification
upon full completion.
Overview:
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
good way to accomplish risk management.
Techniques for risk management
are well established, but require specific interpretation when applied to
software. In this session, we will show a way of knitting risk management into
the development process, so that it is integral to product development, not a
ten ton caboose dragging the train back down the mountain.
Why you should attend:
Perhaps your engineering team is
beginning its transition to an Agile approach - or perhaps you have a seasoned
Agile team and you're just beginning work on FDA-regulated products. You know
that risk management is required, but it's not at all clear how you should
address it as you go through your backlog grooming, iterations, and end-user
demonstrations. The process in ISO 14971 seems "linear" and unsuited
to a highly iterative, dynamic lifecycle. How can you fit it into your
approach?
Areas Covered in the Session:
- Software has introduced
(or been blamed for) some serious safety hazards
- All medical device
standards intersect on the topic of risk management
- Risk analysis starts
with the intended use statement
- Risk information is
available from multipl sources - use them!
- Note that safety is an
emergent property
- Changes are often the
biggest sources of risk
- Don't ignore the human
factors side; understanding your users is crucial to safety
- Applying engineering
risk methods to software requires us to translate some concepts
- Though standards draw a
roadmap for risk management, WE must figure out the route
- Risks often arise when
we add new features - so incremental risk management is the most effective
- Forget the notion that
"software can't hurt anyone"
- Never conduct risk
analysis by using a checklist from 14971
- Exploding technology
brings numerous chances for risk to multiply
Who will benefit:
- Project managers
- Regulatory specialists
- Quality assurance
specialists
- Documentation
specialists
- Test managers
- Software team leaders
and lead developers
Agenda:
Day 1 Schedule
Lecture 1:
Software brings great capability to medical devices,
but also creates hazards
Lecture 2:
Consider how the key standards lay out the roadmap for
managing risk
Lecture 3:
Understand the key concepts - hazard, risk, and harm
Lecture 4:
Walk through ISO 14971 in detail - and consider IEC
80002-1 for specific software concerns
Day 2 Schedule
Lecture 1:
Fault tree analysis and FMEA complement each other for
risk analysis
Lecture 2:
Risk analysis for software is different from hardware
- and needs a place in the lifecycle
Lecture 3:
Story mapping helps bring risk management directly
into development
Lecture 4:
An incremental approach manages both risk and quality
Speaker
Brian Shoemaker
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 manufacturing, contract
lyophilization, clinical trial software, dental prosthetics, and bone-repair
implants. He has worked with companies in Germany and Switzerland as well as
the U.S.
Previous to founding ShoeBar Associates, Brian had
quality roles at PPD Informatics, Doxis, Inc., and Behring Diagnostics, Inc.
Brian earned his Ph.D. in chemistry from the University of Illinois; he has
achieved the ASQ Software Quality Engineer certification.
Location: Baltimore, MDDate: November 2nd & 3rd, 2017 and Time: 9:00
AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON Baltimore,
MD
Price:
Price: $1,295.00 (Seminar
Fee for One Delegate)
Register for 5 attendees
Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
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(Early Bird)
Until September 20, Early
Bird Price: $1,295.00 From September 21 to October 31, Regular
Price: $1,495.00
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attendees Price: $7,122.00 $12,950.00 You
Save: $5,828.00 (45%)*
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