Veeva Systems has announced new capabilities in Veeva Vault RIM for medical devices and diagnostics to manage regulatory documents and processes. Organizations can unify product registrations, health authority correspondence and commitments, and submissions documents on a single cloud platform for one global authoritative source of regulatory information.
Regulatory requirements are rapidly changing, especially with the European MDR going into effect in 2020. Regulatory activities are largely manual, making it difficult to manage the complexity of global submission dossiers and ensure consistency across the end-to-end process.
“Device and diagnostics companies face greater regulatory scrutiny and complexity than ever before,” said Michael Morton, RAC, member of Regulatory Affairs Professional Society (RAPS) board of directors and former vice president of corporate regulatory affairs at Medtronic. “Traditional, manual approaches no longer work. If companies don’t change their model and upgrade to modern technologies, they will struggle to stay compliant and delay getting their products to market.”
Vault RIM now includes new medical device capabilities to streamline processes and drive greater efficiency. Medical device product registration data is modeled to conform with US and EU UDI guidelines. Vault RIM has also expanded to support industry-standard submissions formats such as STED, IMDRF, and 510(k) to improve collaboration and execution across global stakeholders.
Vault RIM applications in the Veeva Vault Medical Device Suite include Vault Registrations for simplified planning, tracking, and reporting on product registrations and health authority correspondence; Vault Submissions for easier authoring and submissions assembly; and Vault Submissions Archive for global access to a complete history of submissions.
Several medical device companies, including a top 20, are among the early customers adopting Vault Medical Device RIM applications to eliminate manual handoffs and fragmented processes globally. Veeva’s entry into RIM for the medical device market builds upon the company’s success in regulatory. More than 180 biopharmaceutical companies use Vault RIM applications for efficient submissions development and greater visibility across end-to-end regulatory processes.
“The addition of RIM to the Veeva Vault Medical Device Suite gives manufacturers tailored applications to manage evolving regulatory requirements and increase collaboration globally,” said Annemien Pullen, director of strategy for medical device and diagnostics at Veeva Europe. “Our regulatory applications allow companies to get ahead of these changes and bring their products to market faster.”
The Veeva Vault Medical Device Suite includes commercial, clinical, quality, and regulatory applications to provide manufacturers with greater visibility, collaboration, and speed across the product development lifecycle. More than 70 medical device and diagnostics companies, including 8 of the 10 largest, are now using Vault Medical Device Suite applications.
Earlier this month, Veeva announced that Alcon, a global medical device company specializing in surgical and vision care products, chose Veeva Vault Clinical Data Management System (CDMS) as its enterprise clinical data management system for electronic data capture (EDC).