We provide technical assistance in 3 major areas: research and development, laboratory testing and patent applications.
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 accordance with 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 draft format.
We facilitate your patent application by relying on research and development information.