We provide technical assistance in 3
major areas: research and development, laboratory testing and
Whether it is a turnkey project or
not, we coordinate with you and our network of biomedical and
electrical engineers to develop and document the research and
development activities that would be an integral part of your
quality system, as per
21 CFR 820.30 and ISO 13485.
We define the laboratory tests that
are required for your regulatory compliance.
We coordinate with the laboratories
within our network (including outside USA) or the ones of your
choice to conduct the testing required for your device, be it
IEC electrical safety, biocompatibility or otherwise, in
US FDA recognized standards,
US FDA guidance documents, as well as other requirements.
Our main goal is to minimize your
costs and waiting time.
We coordinate with the patent lawyers
within our network or the ones of your choice by providing
information about current state of the art, invention details
with sketches or drawings, as well as suggested claims in
We facilitate your patent application
by relying on research and development information.