This is the final post of a 3-part series featuring useful technologies for medical device regulatory affairs professionals at RAPS 2017, featuring innovative data solutions. Part 1, which focused on compliance review and validation tools, can be found here. Part 2, highlighting SaaS and software platforms, can be found here.
In order to produce effective results, regulatory affairs professionals require timely and convenient access to accurate data. Medical research, clinical and usability trials, and recall and complaint data can all play an important part in the regulatory process, and must be managed efficiently.
Over the years, a number of innovative solutions have been developed to facilitate the process of understanding, processing and maintaining large amounts of regulatory data. In this post, we explore three especially useful tools you may want to investigate further at RAPS.
Graematter – SOFIE (Booth 636)
Graematter SOFIE is a patented regulatory intelligence system that allows you to easily integrate information from many different government sources.
Regulatory affairs professionals must guide their companies through a complex and ever-changing web of regulatory requirements. Finding, analyzing and filtering through this data is essential for medical device companies, but the vast amount of government data can make it difficult to identify the right information.
SOFIE simplifies this process by consolidating information from multiple government sources into one source, equipped with advanced search capabilities. It offers support for FDA, HHS, CDRH, ORI, OCI, DOJ and BIS databases, and includes comprehensive data on inspections, warning letters, sanctions, recalls, review times and more.
An especially useful feature is that SOFIE retains documents forever, even after the regulatory bodies have deleted them from their websites. This allows you to find critical documents you might otherwise not have access to.
Tarius – Cross-Country Tables, Expert Summaries, Medical Device ‘Lite’ (Booth 615)
Tarius is a global regulatory intelligence and compliance company that provides subscription-based access to regulatory information for over 100 territories and international organizations worldwide.
Understanding global regulatory requirements can be a formidable task involving many unknowns. The specific rules can vary quite widely for each territory, which increases risk and uncertainty.
Tarius helps make sense of the global regulatory environment through a variety of subscription-based information products. For instance, their comprehensive expert summaries guide you through local submission procedures and reporting requirements based on local hands-on experience by regulatory affairs professionals. Meanwhile, their cross-country tables allow you to compare a wide range of regulatory data from various jurisdictions, in a convenient side-by-side presentation.
In addition, Tarius offers Medical Device ‘Lite’ – a cost-effective solution for smaller-sized medical device companies. This is a web portal that includes information for more than 80 territories and international organizations. The offer is only available to companies with under 500 employees, and allows access for up to 3 users.
Regal Intel – “Sights” Data Analytics Engine (Booth cancelled)
Regal Intel develops the “Sights” Data Analytics Engine, a proprietary tool that enables smart data-driven regulatory decision-making. We thought there product deserve a review though they are not present in this year exhibition.
Easy internet access to regulatory data has led to an information overload problem in the regulatory profession. In performing research, a regulatory professional often encounters many different sets of requirements related to any given device type and market. It can be a difficult task to determine the most appropriate requirements, and the process often involves some degree of personal bias.
Regal’s “Sights” engine solves this problem with a proprietary system for sifting through the noise and accurately resolving regulatory inconsistencies. The technology is made possible through Regal’s extensive data-mining of regulatory information, including regular sourcing of actual requirements from a network of in-country representatives and regional experts.
Regal has been building its extensive resource bank since 1992, and continuously optimizes its data engine algorithms to stay current with the regulatory landscape.
Meet Arazy Group at Booth 300
Arazy Group will also be exhibiting our flagship LICENSALE.com© solution on the RAPS show floor. LICENSALE.com© is the only fully integrated cloud-based global market registration system for medical and IVD devices, offering capabilities in 100+ countries.
Come visit us at booth 300 for a live demo, and to chat about how we can help you with your market access needs.