Survey Finds Medtechs Lack Confidence in Regulatory Data Quality

Rhea-AI Summary

Veeva Systems (NYSE:VEEV) released its 2025 Medtech Regulatory Affairs Benchmark report, revealing significant challenges in regulatory data quality and processes. The study found that 50% of respondents lack full confidence in their global product registration data, while only 17% rate their regulatory data quality as excellent.

Key findings show that 80% of respondents take a month or longer to prepare 510(k) submissions, with 24% requiring over six months. Only 5% use fully automated time-to-market monitoring, while 67% rely on manual processes. Major operational challenges include administrative burden (61%), siloed processes (49%), and digital tool proficiency (35%).

To address these challenges, 56% of organizations plan to adopt regulatory information management systems, while 52% aim to develop system integrations.

Positive

• 56% of organizations planning to adopt regulatory information management (RIM) systems
• 52% of respondents looking to develop integrations between existing systems
• 48% planning to implement automated submission tracking and reporting tools

Negative

• 50% of respondents lack full confidence in their global product registration data
• Only 17% rate their regulatory data quality as excellent
• 80% of respondents take a month or longer for 510(k) submission preparation
• 67% still rely on manual processes for time to market monitoring
• 61% report heavy administrative burden in regulatory affairs

Veeva MedTech report reveals opportunity to move beyond manual processes for speed and compliance

PLEASANTON, Calif., July 30, 2025 /PRNewswire/ -- Veeva Systems (NYSE: VEEV) today announced findings from the 2025 Veeva Medtech Regulatory Affairs Benchmark, revealing that 50% of respondents lack full confidence in the completeness of their underlying data for global product registrations. Many organizations are manually reconciling data to ensure regulatory compliance, increasing the administrative burden for regulatory affairs teams. 

With the rise of new technology to streamline and automate regulatory processes, high data quality is paramount for medtech innovation. When considering effective AI implementation, only 17% rate their regulatory data quality as excellent, with the remainder categorizing it as average or worse.

The report from Veeva MedTech examines the current state of regulatory operations, including:

• Lengthy timelines for submission preparation. From data gathering to internal approval, preparing a submission for a 510(k) takes a month or longer for 80% of respondents, with 24% indicating that it takes more than six months. With organizations spending up to two years on each MDR submission, medtechs that reduce submission timelines can get products to market faster with considerable cost and resource savings.
  
  
• Prioritizing time to market measurement. Only 5% of those surveyed use a fully automated process to monitor time to market, a key metric for effective resource planning. About two-thirds (67%) partially or entirely rely on manual processes, making it difficult to generate accurate and timely performance insights.
  
  
• Room for regulatory operational improvement. Respondents identified heavy administrative burden (61%), siloed processes (49%), digital tool proficiency (35%), and educational shortcomings (24%) as the largest gaps in regulatory affairs, all of which may hinder product registrations and slow time to market.
  
  
• Technology advancing regulatory affairs. More organizations are making strategic decisions to improve efficiency and compliance, with 56% planning to adopt a regulatory information management (RIM) system. Nearly half of respondents are looking to develop integrations between existing systems (52%) or implement automated submission tracking and reporting tools (48%) to gain unified, accessible data.

"The report illustrates key areas to evolve regulatory affairs to a strategic enabler of business objectives through connected, automated processes for increased data reliability and speed," says Seth Goldenberg, president, Veeva MedTech. "As teams are asked to do more with the same resources, addressing operational gaps to foster agility while maintaining compliance in the evolving regulatory landscape will be critical."

The 2025 Medtech Regulatory Affairs Benchmark surveyed a diverse group of 130 regulatory professionals, exploring the most critical challenges facing regulatory teams today. To learn more, read the full benchmark report here.

About Veeva MedTech 
Veeva MedTech helps medical device and diagnostics companies streamline the complete product development and commercialization lifecycles to deliver products to patients with greater speed and efficiency. Veeva MedTech's offering includes applications that advance clinical, regulatory, quality, commercial, and medical operations. For more information, visit veeva.com/medtech/.

About Veeva Systems
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 biopharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves. For more information, visit veeva.com.

Veeva Forward-Looking Statements
This release contains forward-looking statements regarding Veeva's products and services and the expected results or benefits from use of our products and services. These statements are based on our current expectations. Actual results could differ materially from those provided in this release and we have no obligation to update such statements. There are numerous risks that have the potential to negatively impact our results, including the risks and uncertainties disclosed in our filing on Form 10-Q for the period ended April 30, 2025, which you can find here (a summary of risks which may impact our business can be found on pages 32 and 33), and in our subsequent SEC filings, which you can access at sec.gov.

Contact:
Deivis Mercado
Veeva Systems
deivis.mercado@veeva.com

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SOURCE Veeva Systems

FAQ

What are the key findings of Veeva Systems' (NYSE:VEEV) 2025 Medtech Regulatory Affairs Benchmark report?

The report revealed that 50% of respondents lack confidence in their regulatory data quality, 80% take over a month for 510(k) submissions, and only 5% use fully automated time-to-market monitoring.

How long does it take medtech companies to prepare 510(k) submissions according to Veeva's 2025 report?

According to the report, 80% of companies take a month or longer to prepare 510(k) submissions, with 24% requiring more than six months.

What percentage of medtech companies are planning to adopt RIM systems according to Veeva's 2025 study?

56% of organizations are planning to adopt regulatory information management (RIM) systems to improve efficiency and compliance.

What are the main regulatory affairs challenges identified in Veeva's 2025 benchmark report?

The main challenges identified are heavy administrative burden (61%), siloed processes (49%), digital tool proficiency (35%), and educational shortcomings (24%).

How many medtech companies use automated processes for monitoring time to market according to Veeva's 2025 report?

Only 5% of companies use fully automated processes to monitor time to market, while 67% partially or entirely rely on manual processes.