PPO Standards LLC. provides
consulting services on medical device standards and standardization globally. Our specialty is short term consulting on compliance
with key medical device standards including: ● Application of IEC 60601-1 to medical electrical equipment and systems ● Risk management process,
ISO 14971 ● Determining essential performance ● Usability process, IEC 60601-1-6 and IEC 62366-1 ● Software process, IEC 60601-1, Clause 14, ISO 62304 and
IEC 82304-1 ● Quality management systems, ISO 13485
We can also assist your organization in monitoring and tracking medical device standards activities and help you in establishing your own in-house standards management program.
Billing Rate
Our Consulting rate is 150 USD/h with a project
minimum of 6 h. We find questions typically take 1 to 6 hours to answer. We
typically provide a quote for 25 hours to be billed as time is accrued .
Travel and Living Fees
Typically
in the early stages of a project we may see the need for an on-site meeting, so
familiarity of product, staff, and computer records can be gained. Later more
work can be done off-site, at our office and follow up meetings can be done
with tele/video conferencing.
For
Consulting services, if you are local to the Minneapolis area we can visit your
office. Travel and living costs incurred
for on-site meetings are included in our quote. We estimate max travel cost and
bill for actual travel costs with receipts and mileage. For travel over 1 hour
from our office, our quote includes a charge for 1/2 * ( travel time less 2 h
). For flights, travel time = flight time + 2 hours, each way.
For
On-site consulting services, travel and living costs incurred are included in
our quote. We estimate max travel cost and bill for actual travel costs with
receipts and mileage. For travel over 1 hour from our office, our quote
includes a charge for 1/2 * ( travel time less 2 h ). For flights, travel time
= flight time + 2 hours, each way.
