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Automated Report Level Publishing
for 510k and PMA Submissions
for a Medical Devices Company
No more manually merging Microsoft Word files into PDF reports
employees
1
documents / month
1
annual revenue
1
$
The Challenge Related to Manual PDF Report Generation
The company traditionally used manual methods to compile PDF documents for regulatory submissions (510k & PMA), as well as other reports. This involved merging multiple PDFs, which was time-consuming and required various tools. Additionally, managing documents across different systems added complexity. The process included locating and processing individual PDFs, manual merging with bookmarks and table of contents, applying headers, footers, pagination, and ensuring compliance with regulatory requirements such as font size and hyperlinks.
The DocShifter impact
By automating time consuming document merging / report compilation process, this company is now processing medical device submissions faster than ever; accelerating time to market.
%
1
faster time to market
The manual effort of previously merging tens or hundreds of documents into one or multiple PDFs is now long gone; resulting in significant time savings for the regulatory operations team.
%
1
time savings
40% reduction in document processing time, translating into substantial cost savings. The accelerated time to market, combined with enhanced compliance and productivity, resulted in a significant return on investment.
%
1
faster results
Efficiency gains in
automated PDF report generation in medical devices
Designed for Merging Documents into Compliant PDF reports
DocShifter Reports+ is designed to create navigation-rich, searchable, fully technically compliant PDF reports by merging documents into single or multiple PDFs. It is highly scalable, and integrates with your existing systems or workflows. Natively, or using web API.
The software is highly configurable; more than 200 settings allows configurations on how you want to configure your PDF reports. These settings include but are not limited to: creating cover pages, table of contents/tables/figures, merging or splitting documents, pagination, watermarks, headers & footers, image encoding, embedding fonts and many more.
Improved Efficiency and Productivity
The automation capabilities of DocShifter eliminated the need for manually merging documents into one or more PDF reports, and then further manipulating those PDF reports for compliance.
The process is now streamlined with DocShifter. Both merging documents into PDF reports; and ensuring PDF compliance happens in DocShifter. Fully automated; saving valuable time for the regulatory operations team.
'We were using a sledgehammer to crack a nut. After thoroughly testing DocShifter for automating our report publishing, it was incredible to see how much time and effort we will be able to save now.'
