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Regulatory Affairs Technology at RAPS Regulatory Convergence 2017 (Part 1)
On 9-12 Sept 2017, the Regulatory Affairs Professionals Society (RAPS) will be hosting the world’s largest annual gathering of healthcare regulatory professionals in Washington, DC. The 2017 Regulatory Convergence will be held at National Harbor on the DC waterfront, and will feature over 100 different exhibitors during the last 2 days of the event.
Given the large number of exhibitors, it might be challenging to visit all the booths over the course of two days. That’s why we have put together this conference guide to spotlight some of the more interesting exhibits.
This post will focus on two innovative compliance review and validation tools. It will be the first of a 3-part series featuring useful technologies for medical device regulatory affairs professionals at RAPS. The next two articles will feature software / SaaS companies and data companies, and will be published on the 10th and 11th of Sept.
Schlafender Hase – Text Verification Tool (Booth 324)
Schlafender Hase offers the Text Verification Tool (TVT), a powerful, easy-to-use text and graphic verification software suite. Used by many of the world’s leading medical device and pharmaceutical companies, as well as many regulatory bodies, TVT helps to ensure compliant, consistent and error-free documents.
Over the course of a document’s lifecycle, it can go through many iterations. In the process, many unintentional changes can occur, leading to inconsistent versions of the document across the organization. TVT allows you to verify that only the right changes are included in the final version, helping you avoid legal problems from incorrect submissions.
TVT does this by comparing two files and automatically highlighting any differences between them. At a glance, you can see all changes made between the original and final version, and decide which ones should be included.
TVT does not compare the words seen on the screen, but instead matches Unicode values character-by-character. This approach allows you to compare two files even if they are in different file formats, or have a different layout. The software currently supports all major languages, whether left-to-right or right-to-left.
Reed Tech – Reed Tech Navigator for Medical Devices (Booth 215)
Reed Tech NavigatorTM for Medical Devices is a powerful tool that allows you to easily analyze and compare quality and safety data for tens of thousands of medical device products.
Quality and safety research is often a daunting endeavour, requiring a large investment of time and resources. And even after all the data has been collected, putting everything in the right context and comparing a given device to other similar devices can be a very complex task.
Navigator has been designed to streamline every step in the quality and safety risk analysis process. It consolidates over a dozen medical device sources into a single user-friendly interface, allowing you to quickly find similar products and see at a glance which ones have the most adverse events and recalls.
Once you have found the relevant products, Navigator’s built-in analytics tools can generate a variety of apples-to-apples comparison charts, enabling an easy analysis of quality and safety risks. You can also benchmark your products against industry averages for various types of reported problems (e.g. fractures, infections). This can save you hours, or even days of time, compared to manually compiling and comparing the data directly from an FDA database.
Since Navigator is entirely cloud-based, it is easily accessible from any web-enabled computer, tablet or smartphone.
Come Visit Us at RAPS
Of course, Arazy Group will also be attending RAPS – come visit us at booth 300. We will be featuring our LICENSALE.com© solution – the only fully integrated cloud-based global market registration system for medical and IVD devices, offering capabilities in 100+ countries.