RegDesk's application builder makes use of AI-powered software to construct submission dossiers and autofill applications with the archived product and regional targeting data.
FREMONT, CA : RegDesk, a company that develops regulatory approval tools, has updated its 'Dash' platform. Dash 2.0 includes a revolutionary application builder that reduces the time it takes to submit an application from months to hours and allows for quicker approvals. Creating life-saving medical devices is just half of the fight in the medTech industry. What is left is months, if not years, of fighting to get them accepted in markets all over the world.
In recent years, registering medical devices has become more complex as countries struggle to amend legislation in response to rapid technological developments in the industry. As a consequence, approval procedures are always complex and vary from country to country. According to Elsevier, it takes an average of three to seven years for a medical device to obtain approval and enter a new market.
“We are proud to represent the companies that drive innovative, life-saving technology into new markets around the world,” said Priya Bhutani, Chief Executive Officer, RegDesk. “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.”
RegDesk's application builder makes use of AI-powered software to construct submission dossiers and autofill applications with the archived product and regional targeting data. According to internal data, 40-50 percent of such applications can be completed with only one click. The tool speeds up application development and ensures that each nation's regulatory requirements are met. Non-compliance with various and ever-changing global regulations is a common roadblock for medical device applications. Frequently, applications are refused several times due to minor clerical errors such as out-of-date forms and improper document formatting and ordering.
"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 guides users through the application process using the web's largest and most up-to-date global regulatory information database, potentially saving devices from years of regulatory limbo. RegDesk provides users with a personalized dashboard, and it often collaborates with businesses to incorporate unique functionality and design elements to improve performance. Additional functionality to assist regulatory teams will be available in the coming months, according to the company.