Veeva adds to Vault regulatory capabilities for medical devices, diagnostics

29-Aug-2019 - Last updated on 29-Aug-2019 at 18:19 GMT

(Image: Getty/Denis Isakov)

Veeva Systems has boosted its capabilities in its Veeva Vault RIM to manage regulatory documents and processes for medical devices and diagnostics manufacturers.

According to the company, the expansion will enable organizations to unify product registrations, health authority correspondence and commitments, as well as submissions documents on a single cloud platform.

Medical device product registration data is modeled to conform with US and EU Unique Device Identification (UDI) guidelines and supports submissions formats such as Summary Technical Documentation (STED), International Medical Device Regulators Forum (IMDRF), and 510(k).

The medical device and diagnostics market is expected to reach $409bn by 2023, increasing at a growth rate of 4.5%, explained Terri Howard, director of medical device and diagnostics strategy for Veeva Systems.

“The increasing geriatric population and focus on personalized medicines to treat chronic diseases such as cardiovascular and renal disease are two major drivers for the growth of new and advanced forms of diagnostic testing – and are contributing to the need for better technology in this industry,” she told us.

This, paired with increased regulatory burden, financial pressures, and market access challenges, Howard said there is an “urgent need for device and diagnostics companies to increase agility and get their innovations to market fast.

“Prevailing technology no longer cuts it as many manufacturers are still using multiple share point sites and Excel spreadsheets to manage and track submissions ⁠— which sufficed a decade ago but market forces and the regulatory landscape are dramatically different today,” said Howard.

“These manual processes and disparate systems limit visibility and make it difficult to ensure consistency across the end-to-end regulatory process,” she added. “It causes delay at every step and ultimately, slows innovative products from reaching patients.

Earlier this month, Veeva announced Vault Safety.AI, which will be integrated to its cloud-based suite, available in April 2020.

Safety.AI automatically converts text input from sources including social media, fax, email, literature, and call center notes and fills the required fields in a drug safety case, according to the company.