Product design phase
Ideally, you should contact us once you determine the
laser requirements of your project. With over two decades of laser
product engineering experience, we can improve not only the regulatory
aspects of your laser design, but we also may be able to improve
performance, lower costs, and find a "perfect match" supplier.
No matter where you are in the engineering and
production cycle, give us a call. Even a last-minute change may make the
difference between easy acceptance or a rocky regulatory road.
Initial product reporting
If your product is already
in production, we generally advise that you contact us at least three months in advance of your
market introduction -- what the CDRH calls "introduction into commerce".
Recall that this covers the first appearance at a trade show, or the first
advertising or offering for sale.
This three-month period gives us time to schedule your
work, to understand your product, to prepare recommendations and to plan
for governmental review of reports.
Rush/overtime service available
We understand that project
scheduling sometimes requires rush or overtime work. We can provide this
service as well.
|