Webinar: Tracking Medical Devices – How to Manage UDI Compliance Readiness

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Location and Date: Orange County, CA – 4 November 2015, 11:00am-11:40am PST – Portford Solutions Group

Portford Solutions Nick & Bruce Bolton and Axcent Advanced Analytics Joe Buonomo to co-host an online event about how the rapidly changing FDA regulatory requirements affecting medical device tracking will be accommodated by Portford Solutions’ agile-based development strategy and implementation for their best-in-class SaaS solution.

The first in a series of Webinars to be held on November 4, 2015 to discuss the important regulatory requirement of coming into compliance for with the new FDA regulation for Unique Medical Device Identifier requirements. Portford Solutions will be sponsoring this first in a new Symposium series and will discuss how their current offering complies with the beginning of the FDA requirements for device tracking. Central to this offering is the creation of a Software as a Service (SaaS) platform, a cloud-based solution that is a best-in-class model for both its cost-effectiveness and ease of deployment to solve a wide range of medical device business challenges.

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Medical Device Tracking: Rapidly Changing USA and Worldwide Regulatory Environment

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The September 2013 FDA Final Rule on UDIs for medical devices is now law!   So what does this mean for Medical Device industry? It means that imminently, medical device manufacturers will have to upgrade their labeling and packaging systems along with their data management capabilities in order to stay compliant with incoming regulations and […]

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Medical Device Tracking – The Next Generation

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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.

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