Qsite is a professional, experienced, consulting group focused on the medical device industry.
Our services include advice on international regulatory affairs, clinical affairs, biostatistics and global Quality Assurance (QA).
Our experienced team consists of experts in regulatory affairs, product manufacturing and testing, facility inspections, statistics and clinical trial design and evaluation. Our familiarity with the regulatory process will help you to bring your product to the market.
Clearance and registration of US FDA, European CE, Canadian, Japanese PAL and other international regulatory agencies.
Implementation of quality systems, procedures and documentation processes to meet international regulatory requirements.
Software Validation procedure and protocol, and preparation of Software submission Files.
Clinical study design, protocol and CRF preparation, Clinical regulation (GMP) study monitoring, data management and reporting.
Biostatistical consultation, data analysis, SAS programming.