Veeva Systems (NYSE:VEEV) said today that it has added capabilities in its Veeva Vault records information management (RIM) platform to manage regulatory documents and processes for medical devices and diagnostics.
The upgrade will allow organizations to unify product registrations, health authority correspondence and commitments, and submissions documents on a single cloud platform for one global authoritative source of regulatory information, according to the Barcelona-based company.
Regulatory requirements are rapidly changing, especially with the European MDR and IVDR going into effect in 2020. 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.
“Device and diagnostics companies face greater regulatory scrutiny and complexity than ever before,” said Michael Morton, a member of the Regulatory Affairs Professional Society (RAPS) board of directors and former VP of corporate regulatory affairs at Medtronic, in a news release from Veeva. “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.”
“The addition of RIM to the Veeva Vault medical device suite gives manufacturers tailored applications to manage evolving regulatory requirements and increase collaboration globally,” added 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.”