Veeva Systems officials announce that Veeva Vault is helping a growing number of medical device and diagnostics companies improve quality and efficiency to meet new compliance standards. In less than one year, Veeva has seen nearly 25% growth in medical device and diagnostics customers as organizations prepare to meet rigorous compliance requirements from global health authorities and the international standards organization (ISO). Now, nine of the world’s top 15 medical device companies are implementing Veeva Vault, including leaders such BD (Becton, Dickinson and Company).
New compliance requirements are expected to significantly impact medical device and diagnostics operations. Beginning March 2019, the 2016 revision to ISO 13485 will require that risk management is incorporated into every aspect of the quality management system. Additionally, the European Commission ratified new medical device regulations for all European member states, while the U.S. Food and Drug Administration (FDA) released more than a dozen new medical device guidance documents in 2016 and 2017 that set new expectations for risk assessment.
“We needed a scalable, global, and easy-to-use content management solution that would adapt to expanding business and compliance needs, and meet multiple stakeholder requirements. Veeva Vault transforms how we access and manage critical documentation,” says Orit Magyar, head of quality systems and processes at Coloplast. “We are already seeing faster document approval and tighter control. And, with real-time visibility, we can see where content stands, so bottlenecks or problems can be resolved immediately – not weeks later.”
Similar to Coloplast, companies are adopting Veeva Vault to increase collaboration, transparency, automation, and efficiency. Veeva Vault is the only platform and suite of cloud applications designed to manage regulated content and data across the product lifecycle. From discovery to product design in clinical, quality, and commercial, Veeva Vault ensures global consistency that device makers need to meet today’s challenges, stay compliant, and continuously innovate.
“Medical device and diagnostics companies recognize the urgent need to improve content and data management across functions, and are turning to Veeva as a proven cloud technology provider,” states Melonie Warfel, vice president of medical device and diagnostics at Veeva. “Customers can unify their processes from end-to-end with Veeva Vault to increase quality and efficiency while gaining valuable insights across the product lifecycle that they can build upon with each new product in development.”