Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,000 customers, ranging from the world's largest pharmaceutical companies to emerging biotechs. New research from the Hacienda-headquartered company shows that a majority of medtech organizations are taking action to advance regulatory affairs.

The Veeva MedTech 2022 Year-end Regulatory Benchmark Report examined the medical device, diagnostic, and digital health industry's progress towards modernizing regulatory operations by gathering the experiences of regulatory affairs professionals from nearly 100 medtech organizations around the globe, ranging from enterprise to midsize businesses, according to the company. The study explored how medtech companies manage global compliance and visibility, speed to market, postmarket, and regulatory modernization.

According to the second annual Veeva MedTech Year-end Regulatory Benchmark Report, more than half of medtech companies say establishing a single source for regulatory information (62%) and implementing a global and centralized regulatory information management (RIM) system (51%) will be the industry's top focus over the next two years. With the move to modernize RIM underway, medtech leaders are bringing together data, content, and systems for improved insights and time to market, according to Veeva.

The company's survey data reveals an increased focus on digital systems to harmonize operations globally, with two out of every five companies already selecting digital regulatory technology. This shift toward digital RIM systems highlights the need for greater transparency and collaboration across regional teams to meet evolving regulations and change management requirements. The report reveals positive changes to regulatory affairs as well as opportunities for improvement.

According to the survey results, manual processes still linger, the use of single systems for registration data is growing, and post-market compliance processes lack connections. More specifically, only 13% of companies have implemented a global digital RIM system for end-to-end management of regulatory operations. Many medtech organizations rely on manual processes, disconnected data sources, and siloed systems that aren't scalable, making it harder to expand into new markets. Companies that collect global registration data in a single system increased year-over-year, highlighting urgency for establishing one source for regulatory information. Finally, 83% of the companies surveyed use partial integrations, point solutions, or manual processes across regulatory and quality to capture post-market changes within the product portfolio. The lack of a seamless and automated change control process increases risks and can lead to compliance issues or delays, Veeva reports.

"With new regulations and increasing supply chain complexity, medtech companies are evaluating paths to more seamless processes so high-quality data can be shared across teams," according to Seth Goldenberg, Vice President of Veeva MedTech. "This research shows the medtech industry is making progress by advancing regulatory operations for better global visibility, data accuracy, and compliance."

The Veeva MedTech Regulatory Benchmark Report examines the medical device and diagnostic industry's progress toward modernizing regulatory operations. Survey respondents include regulatory affairs professionals from more than 100 medtech organizations around the globe, ranging from enterprise to midsize businesses. The full annual study explores how medtech companies manage global compliance and visibility, speed to market, post-market compliance, and modernization.

For more information about Veeva, please visit www.veeva.com.

To register for a copy of the Veeva MedTech 2022 Year-end Regulatory Benchmark Report, please visit www.go.veeva.com/regulatory-benchmark-fdanews.