ularly frustrating to medical device teams
because they are often not available in
print for quick reference. Nonetheless,
these unwritten rules are the landmark of
an evolving industry, and may be vital for
a particular product. A testing expert will
guide a development team through the
process of choosing the right combination of testing components.
Informative Annex A. 7 of the ISO
11737-1:2006 standard offers an example
of a potential roadblock that a testing ex-
pert could help avoid. This clause states,
“If the percentage recovery is found to be
less than 50%, improvements to the tech-
nique or the use of alternative techniques
should be considered.” This text appears
in an informative annex with the word
“should” as opposed to “must.” Usually a
“should” statement in an annex is consid-
ered voluntary guidance. However, this
sentence has been interpreted by many
regulatory bodies as a requirement, as if
it were a “must” in the main body of the
standard. If the right people are involved
prior to the regulatory submission, they
will know to direct the laboratory to per-
form additional testing before submission.
4. Remember Things Evolve
Just because testing performed several
years ago was successful doesn’t mean
the same testing should be performed
for a regulatory submission today. This
type of thinking can unfortunately lead
to regulatory submissions being rejected.
Re-evaluate the testing plan with each
submission to ensure the right combination of tests are chosen.
5. Test GLP
When submitting samples for laboratory
testing, the question of whether or not
GLP (good laboratory practices) testing
is preferred will be asked. GLP involves
additional quality assurance steps. With
GLP testing, at least one active phase of
the study will be audited by quality assurance personnel. Additional documentation
and quality assurance signatures are also
part of the GLP final report. Due to these
extra quality measures, GLP testing is the
preferred method for studies being submitted for a regulatory submission and are
sometimes preferred for testing performed
to evaluate device material changes, or
testing related to in-house validations.
Without the support of a skilled laboratory
testing partner and consultant, the long-term success of a medical device depends
largely on the in-house device team’s
ability to establish a robust enough test
plan and document the rationale behind
those decisions. It goes without saying
that the testing landscape is complex, and
should not be navigated alone. Many of
the critical errors encountered in outsourc-ing medical device testing and regulatory
submissions can be avoided or mitigated
with the help of these experts. MDT
For more information, www.nelsonlabs.com.
A World Apart
In a World of Parts!
Precision Chemical Etching
Our process of photochemical etching
offers the speed, flexibility and
precision demanded by
• Part to print in 1 day... yes, we’re that fast!
• Our technical staff will drive
your project, even without a print.
• Unlimited flexibility and complexity!
• We can form, plate, assemble and
package your parts...
Just tell us what you need!
You’ll see the difference as soon as you
talk to us. Contact our sales staff or request
your free sample kit and design guide at
773.463.6211 3758 W. Belmont Avenue
FAX.463.3387 Chicago, IL 60618