Our professional team with its vast experience in a variety of technologies and medical devices enables us to develop creative approaches to assist you in bringing your products to market in the United States, Europe, Canada, and other markets.
Our professional staff is trained to assist you in:
Qsite provides a full range of regulatory assistance and support to medical device companies.
Design, assess, and implement quality systems, procedures, and documentation to meet U.S. FDA QSR/GMP, ISO standards, European Medical Device Directives, Canadian Medical Device regulations and other medical device authority requirements.
Software Validation procedure and protocol, and preparation of Software submission Files.
Qsite provides a range of pre-clinical and clinical study services. We have vast experience in designing pre-clinical and clinical studies in complaince with regulatory requirements (ICH/GCP).
We have experienced biostatisticians and may implement these tools for clinical, pre-clinical and performance testing.
Turning your product into reality