Growing regulatory complexity driving need for a
single source of regulatory information
PLEASANTON, Calif., Nov. 15,
2023 /PRNewswire/ -- Most medtech companies (87%)
can't seamlessly exchange product information between in-country
and global regulatory assurance teams, according to the 2023
Regulatory Benchmark Report from Veeva MedTech. Without a
standardized and consistent way to share documents globally,
organizations can't ensure the reliability or accuracy of product
information across markets. This increases compliance risk and can
delay the delivery of devices and diagnostics to patients.
A single source for regulatory documents can enable global teams
to access real-time information and take proactive action. Yet,
more than half of respondents (56%) say they don't have access to a
single source for documents to support global submissions. As
regulations — like EU Medical Device Regulation (MDR) and In Vitro
Diagnostics Regulation (IVDR) — continue to evolve, establishing
centralized regulatory data and documents should be a top priority
to accelerate approvals and speed up new market entry.
The report reveals additional opportunities for improving
medtech regulatory affairs, including:
- Cross-functional collaboration is still manual: More
than one-third (35%) of companies rely on status meetings to share
regulatory plans across functions. This obligates individuals to
communicate vital information, reducing visibility and data
quality.
- Misaligned content increasing risk: The majority (75%)
say key content, such as intended use or device descriptions, is
misaligned across functions at least some of the time. With the
variance in information, companies face an increased risk of
inaccurate or incomplete regulatory submissions.
- Greater need for harmonized claims management: Just 14%
of respondents say their entire content lifecycle process is
optimized across functions. At the other end of the spectrum, over
a third (34%) say they conduct siloed content reviews or have no
clear review process. With this disconnected approach, regulatory
teams report they often lack the evidence needed during product
claim audits.
"As companies scale and expand into global markets, having
real-time, accurate product information can significantly
streamline in-country regulatory submissions," said Seth Goldenberg, vice president, Veeva MedTech.
"The research reveals a significant opportunity for medtechs to
unify global regulatory information, a shift that can empower
regulatory affairs with data for faster approvals."
The Veeva MedTech 2023 Regulatory Benchmark Report examines the
medical device and diagnostic industry's progress toward
modernizing regulatory operations. Survey respondents include more
than 100 regulatory affairs (RA) professionals from medtech
organizations around the globe. See the complete annual study,
which explores how medtech companies and RA teams work
cross-functionally to manage new product development, global market
entry, commercial launches, and renewal of product
certifications.
About Veeva Systems
Veeva (NYSE: VEEV) 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.
Contact:
Deivis Mercado
Veeva Systems
925-226-8821
deivis.mercado@veeva.com
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SOURCE Veeva Systems