Houston, TX (March 25, 2021) — RegDesk, a regulatory approval software company, has released an updated version of its ‘Dash’ platform. Dash 2.0 incorporates an innovative application builder that cuts the submissions process from months to hours and facilitates faster approvals.
In the ‘medtech’ industry, creating life-saving medical devices is only half the battle. What remains is months, often years, of struggling to get them approved in markets worldwide.
“We’re proud to represent the companies that drive innovative, life-saving technology into new markets around the world,” said RegDesk Chief Executive Officer Priya Bhutani. “We know that device manufacturers are struggling to keep up with the pace of change in our industry and need to eliminate the redundancies in their jobs.”
Registering medical devices has become increasingly challenging in recent years as nations struggle to update regulations in response to rapid technological advances in the industry. The result is labyrinthine approval processes that often differ from country to country. According to Elsevier, it takes a medical device between three to seven years on average to gain approval and penetrate a new market.
RegDesk’s application builder uses AI-powered software to automatically prepare submissions dossiers and autofill applications with archived product and regional targeting information. Internal data shows that with one click, on average, 40-50% of certain applications can be completed.
Besides faster application building, the tool also ensures greater compliance with individual nations’ regulatory requirements. A common roadblock for medical device applications is non-compliance with diverse and ever-changing global regulations. Often applications are rejected multiple times for minor clerical issues such as outdated forms and incorrect formatting and ordering of documents.
RegDesk utilizes the largest and most up-to-date global regulatory intelligence database on the web to guide users through the application process, potentially saving devices from years of regulatory limbo.
“Since implementing RegDesk, we’ve been able to meet compliance thresholds almost immediately, as opposed to the unreliable guess-and-check methodology we used to employ,” said a senior regulatory affairs associate from a Fortune 500 company. “Intuitive tools like this are changing the industry for the better, as we’re able to keep life-saving medical devices in the market longer and, in addition, get new technologies to people who need it faster.”
RegDesk offers a customizable dashboard to users, often working with companies to add special features and design elements in order to maximize efficiency. In the coming months, the company will be rolling out additional features to support regulatory teams.
RegDesk works with leading medical device manufacturers in the U.S. and around the world. The company was created in 2014 to simplify a complex, decentralized international regulatory system by using artificial intelligence. The team is based in Texas and currently hiring software sales professionals to work remotely.