May 6, 2020

The increasing availability of digital regulatory affairs and quality assurance (RA/QA) tools for medical device and IVD market access stands to enable manufacturers to register their products and maintain compliance across multiple jurisdictions while avoiding costly manual labor efforts. Conversion of the industry to the benefits of more automated RA/QA processes is currently very much a work in progress, however.

According to Emergo by UL’s Global Medical Device Industry Outlook for 2020 surveying more than 1,800 medical device and IVD manufacturers, awareness of digital RA/QA tools has increased among companies of all sizes, but implementations of such technologies have so far occurred primarily at larger firms.

Defining digital RA/QA capabilities, and benefits

In general, digital or automated RA/QA tools may include:

  • Monitoring and alerting capabilities for market regulatory changes and updates
  • Technical file and documentation preparation for US FDA 510(k), European CE Mark certification and other regulatory submissions
  • Time-to-market estimate calculators
  • Automated quality management system components

Benefits of adopting digital RA/QA systems depends on several factors: size of the manufacturer, number of markets they’re targeting, types and risk profiles of their products, as well as the depth and breadth of their own internal RA/QA resources. For smaller manufacturers with slimmer product portfolios and limited manual resources, automated RA/QA tools provide more scalable, cost-effective market access; for larger manufacturers with more substantial resources, digital RA/QA capabilities can help realize operational efficiencies and deploy their internal RA/QA staff more strategically.

Early-stage uptake

Based on Emergo by UL survey results, automated RA/QA technology adoption rates remain in a relatively early stage, with 29% of respondents indicating they have already implemented digital tools to address significant portions of their RA/QA processes. However, another 39% of firms reported they were considering automated RA/QA options, while a clear minority of companies (32%) indicated continuing reliance on manual processes.

So far, digital RA/QA tool implementation primarily involves larger manufacturers: 56% of companies with more than 250 employees and 44% of firms with more than 1,000 employees participating in our survey utilize automated RA/QA technologies. As these tools as well as the cost and operational benefits of using them become more established among top-tier manufacturers, a wider variety of medical device and IVD companies will drive up implementation rates. Based on our survey results, most firms are already considering their options.

Learn more about RA/QA automation issues at Emergo by UL:

  • Regulatory Affairs Management Suite (RAMS) cloud-based RA/QA support
  • RA/QA consulting for medical device, IVD and combination product manufacturers
  • Medical device and IVD registration and approval consulting
  • Webinar: RAMS utilization for medical device RA/QA management



  • Stewart Eisenhart