The tool potentially reduces the overall lead time for conducting post market clinical follow-up (PMCF) surveys to approximately 40 percent compared to conventional methods. To keep the devices on the market, manufacturers must continuously and proactively collect end user feedback to support and document clinical claims.
A PMCF survey can fulfil this requirement and be a potentially good approach for collecting real world evidence to ensure continued safety and performance of live saving medical devices. However, manufacturers face multiple challenges for conducting these surveys which hinders the timely submission of regulatory documents to the notified bodies.
FastPMCF is designed to resolve many of these challenges as it supports building a questionnaire, distribution of surveys, data collection and customized analysis report.
Our tool enhances the experience of conducting PMCF survey by automating the process of creation, distribution and obtaining responses, said Kuldeep Tyagi, CEO and Managing Director of SARACA Solutions. Our knowledge of the global regulations and experience of supporting medical device clients as they report to the notified bodies allowed us to develop this platform. By developing this unique tool, our endeavor is to move a step further in assisting our customers by resolving their challenges of regulatory submissions.
About SARACA Solutions
SARACA Solutions, founded in 2014, is a leading global engineering services company providing solutions and services in quality, regulatory, clinical, mechanical engineering, embedded and electronics hardware and software development for the medical device industry. The company is based in Boston, MA, and Fairplay, SC, with its headquarters in New Delhi, India.
Their offerings range from end-to-end solutions to customized services to medical device manufacturers. Their service-oriented team of regulatory and clinical experts, engineers and designers possess extensive medical industry experience and has a keen understanding of the challenges faced by medical device companies.
SARACA provides cost-effective customized solutions for market segments including orthopedic, cardiology, medical software, neuromodulation, radiology, surgical, ENT, imaging Systems, remote patient monitoring, and laboratory equipment. Learn more by visiting www.saracasolutions.com or email contact ( @ ) saracasolutions dot com.