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AlvaMed News
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AlvaMed
now offers design control training sessions
tailored to your specific needs.
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AlvaMed
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AlvaMed offers consulting services to
medical device industry clients, using our
depth of experience to solve issues by
identifying, planning and executing new
product and business opportunities.
AlvaMed's mission:
"to bring
commercial value to the brilliant ideas of
others."
- Thomas Alva Edison
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Dear Reader,
Welcome to the first AlvaNews. In this
issue, we will discuss the potential
impact of the recent Supreme Court
Ruling on medical device liability, and
how it could relate to your Risk
Analysis efforts. Need more information?
Please
call us at 781.710.2418. Thank you.
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SUPREME COURT RULING AND YOU |
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 Personal
Injury Lawsuits on the Wane?
The recent Supreme Court ruling
on Medtronic could reduce personal injury
lawsuits alleging design "flaws." However,
defective manufacture allegations could
increase. Will your product stand up to this
increased scrutiny? You can mitigate your
risk with proper use of failure modes and
effects analyses...
read more.
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PAIN-FREE FMEA? |
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Risk Analysis Can Save You $$
Turn the "pain" into "gain" with expertly
executed risk analyses. Click to see 5 tips
to improve this often painful process.
Read more...
Definition Dilemma
What is ALARP? What is harm vs.
hazard vs. risk? Get everyone on the same
page, click
here.
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RECENT
PROJECTS
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 Finding
the Best Path Forward
AlvaMed's team rapidly and successfully
developed and presented a plan for a major
pharma company, interested in licensing a
new medical device technology and lacking
medical device experience.
AlvaMed's efforts helped the client form the
basis of a fair, negotiated deal. Read
more...
Doing the Right Things Right
A startup company was outsourcing product
development engineering and manufacturing.
AlvaMed helped improve the client's risk
management system by:
- revising and improving risk
management SOP to accommodate the
increasing size and complexity of the
company
- developing and implementing risk
management plan templates to facilitate
future efforts.
Read
more....
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Thank you for taking the time to read
our newsletter. We look forward to
hearing from you.
Sincerely,
AlvaMed Marketing Team
AlvaMed, LLC |
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