G et to the Finish Line First with
the New BSI CE- 45 Program
EXPERTISE • GLOBAL ACCESS • SPEED-TO-MARKET • CONFIDENCE • PARTNERSHIP
Are you Prepared and
Ready-to-Go
to European Markets?
The new BSI CE- 45 Fast Track Program, for medical devices
needing CE Marking design dossier reviews, has been developed
to complete reviews for European Markets in 45 working days.
You have been diligently working towards this moment to launch
for countless months—or for years. Your company has likely
invested heavily, stakeholders are pressuring for launch and
patients are awaiting the product. Now it’s time for the final step,
an independent verification that the product is indeed ready.
But where do you go to find a company that cares about your
launch as much as you do? Straight to BSI, Healthcare.
We can help you be first
to cross the finish line
BSI is a Notified Body governed by the highest of standards to
ensure effectiveness, safety and independence. We offer you a
dynamic, technically advanced environment which encourages
open communication so we can work together to achieve
this goal.
Contact us at 800 862 4977
or Email Healthcare@bsigroup.com
Visit: www.bsiamerica.com
Like auto racing, combining skilled drivers with high-speed
and high-performance vehicles, BSI, Healthcare uses the best
and most knowledgeable Product Experts implementing
state-of-the-art technology all designed to handle the twists
and turns in the regulatory road with ease.
The Notified Body
of Choice
The CE- 45 Program does not guarantee a CE Marking certificate will be issued in 45 working days, but is based on completing review process
with either a positive or negative recommendation. It excludes reviews outside BSI’s control (e.g., medicinal, animal and/or blood products).
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