fda, stabilities, 510K, ide, pma, iso, data
submissions, protocols, regulations, accelerated aging, stress testing,
modeling, experimental design, product claims, design controls, ce mark,
experts, consultants, medical devices, pharmaceuticals, documentation,
safety, efficacy, labeling,stability studies
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We have thorough
knowledge and expertise in the evaluation of plastic, metallic, glass,
woven and non-woven fabric materials as well as various solutions and
mixtures. These evaluations have included stability, accelerated aging and
actual failure of a material or product during normal use.
We have completed
product performance studies concerning the effect of radiation, E-Beam,
ethylene oxide and steam sterilizations as well as temperature, humidity,
pressure, vibration and time.
We have been involved
in the successful transformation of numerous faulty product designs and sub-optimally
operating manufacturing processes.
Available Services
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Develop statistically valid stress and other accelerated
aging studies which can simulate real time product aging
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Implement
already proven win-win strategy for getting total FDA cooperation and
fast product approval
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Invent,
design and validate laboratory test methods for completion of stability
studies
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Stability Studies, Accelerated Aging, Stress Testing
and Forced Degradation
Stability
studies should include some degree of forced degradation testing,
more commonly called as accelerated aging or stress testing.
Even though there are
no detailed guidelines that one should follow in developing this type of
testing, here are a few pointers:
1. Thoroughly
understand how the product will be used and what are the conditions
of warehousing, storage before use at the distributor's/customer's sites.
2. Fundamentally
understand the underlined engineering and other scientific principles that
control product performance and quality.
3. Simulate in the
lab "worst case scenario" conditions for a given product, and
evaluate the product's performance. Here it is very important to
remember that simulations are just that: simulations; real life could be
more or less different.
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TechnoBusiness
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403 Christie Ct.,
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Costas B. Chantzis,
CEO
Tel.:
908.387.9276
Fax: 908.387.0447 Email
Home
Home
Who We Are
Unique Strengths
Our Services
Projects Resume
Your Next Step
Write Us
What's New
Articles
Ask
SolvWizSM For FREE
TechnoBusiness
Solutions
403 Christie Ct.,
Stewartsville, NJ 08886 USA
Costas B. Chantzis,
CEO
Tel.:
908.387.9276
Fax: 908.387.0447 Email
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