Our Commitment for Best-in-Class Medical Device Management Solutions
To complement our strong expertise in Medical Device Tracking workflow development, we have been actively working to enhance our whole collection of software and service offerings to meet the rapidly changing regulatory environment facing the device industry. One of the greatest obstacles and concerns for the industry is the nascent and coming regulatory changes (1) being imposed upon the industry; the larger the company, the greater this burden is reported. In addition, there is always a core goal for providing health outcomes that meet the best practice that can be delivered for the medical community – Is what we manufacture and aid in the delivery to patients, safe and effective?
At Portford, our stated systems development direction for both core software and services will fill this shortcoming by providing all the requirements for medical device tracking, patient clinical data collection and regulatory reporting. In addition we will be offering advanced data analytics and predictive analysis integrated into our workflow-based medical device tracking software to report on trends in device stability, performance and providing early detection of problems with devices before they become an issue for the companies, regulatory agencies and the patient population. From a recently published report (2) it has been determined that the 510(k) program is in need of modification to support both patient safety and efficacy concerns.