Global Life Sciences Regulatory Environment

The life sciences industry Life sciences (medical devices, pharmaceutical, biotech) have some of the most stringent regulatory landscapes in the global economy. In fact, as of the publication of this article, “[t]here have been more than 2,000 regulations introduced by the FDA alone since 1998 — a compound that by the 150 regulatory bodies at the country level globally for a more general sense of what companies are up against when it comes to compliance regulation adherence.”¹

In recent years, however, the life sciences regulatory landscape has become even more complex as regulators strive to reconcile regulations, public health, and patient safety with technology advances and increased global distribution of life sciences products. For life sciences companies to compete successfully in international markets, they must not only keep abreast of the latest regulatory developments but must ensure full compliance, something that has certainly not been lost to global life sciences CEOs. In its “21st CEO Survey: Preparing for disruption”, PricewaterhouseCoopers (PwC) surveyed 70 pharmaceutical and life sciences CEOs from 31 countries. When asked how disruptive changes in industry regulations would be for their business over the next five years, 53% of respondents indicated that the regulations would be “somewhat” or “very” disruptive.

Chart of Top Disruptive Business Trends for Pharmaceutical and Life Sciences

Data Source: PwC²

Part of the proliferation of regulatory changes has involved more stringent requirements for life sciences software localization. Since the FDA³ and the EMA⁴ now recognize software intended for medical purposes as a medical device, this software is subject to the new and evolving regulations in each of these regions. Software localization ensures all aspects of a company’s medical device software — such as website patient portals, mobile apps, and medical device mechanics — are clearly and easily understood by the end-user in each market’s official (or preferred) languages. As such, software localization goes well beyond professional translation by adjusting your product’s software on both a linguistic and cultural level.  

Life Sciences Software Localization

Life sciences software localization is a critical part of placing medical devices — and maintaining their availability — in the global marketplace throughout a product’s life cycle. The entire process of software localization involves five main steps, namely:

✓ Extracting source files

✓ Translating the UI strings into each required language

✓ Reviewing translation for accuracy and quality

✓ Importing translated files into your software

✓ Reinstalling the UI strings into the original code structure

✓ Screenshot verification to ensure proper translation representation in the software platform

However, since software localization must take into consideration each region’s cultural specificities, it also involves the verification and appropriateness of images, symbols, date and time structures, and currencies, among other considerations. To ensure overall success, software localization should also involve linguistic validation and quality assurance, along with functional and cosmetic testing. Because this process requires very nuanced skills and expertise, it is critical to a company’s continued global success to work with a language services provider (LSP) well versed in life sciences software localization. Partnering with a specialized LSP will help you remain compliant without slowing down your product’s time to market.

Partnering with  Experienced LSP Companies

Software localization errors risk damaging your company’s reputation. These errors can also risk public health and patient safety, and delay new product launches. However, for many life sciences companies, in-house localization teams are not a reality. In such cases, an LSP specialized in life sciences software localization can become a company’s secret weapon. Specialized LSPs ensure localization consistency and help increase overall translation quality by eliminating errors throughout the process. Through the application of translation tools, terminology can remain consistent on the first screen through the 350th screen. Additionally, LSPs of this caliber offer an experienced team of software engineers and seasoned linguists that help expedite your product’s market launch, manage your product’s life cycle, and meet each of your scheduled deadlines. Ingenuiti is one such LSP.

Steadfast Commitment to Excellence in Software Localization


User experience is critical for all technologies and is especially critical for those in life sciences where quick access to information could impact public health and patient safety. As such, life sciences companies invest considerable time, resources, and finances in order to successfully place their products on international markets. Ingenuiti is not only TÜV-certified to crucial ISO quality standards but our expert linguists and software localization specialists empower our clients to implement our mature localization systems which provide timely delivery of your localized product software. 


Ingenuiti offers 30+ years of success supporting life sciences clients as their trusted localization service provider. Over a span of more than three decades, Ingenuiti has supported thousands of successful projects and offers a project management team with an average tenure of 25+ years in software localization. Throughout the years, we have supported organizations with localization and testing of their User Interface (UI) displays, including those used for the medical device industry and technologies relating to clinical trials. Quite simply, Ingenuiti has millions of words translated with proven quality and testing processes under our belt.


Ingenuiti provides a centralized project portal for requests, communication, visibility, and delivery. We also support API connections with content management systems. REVISE — Ingenuiti’s proprietary translation review tool — empowers our teams to professionally, accurately, and efficiently manage in-country reviews and validations, simplifying the QMS documentation process. Our established quality processes coupled with our proprietary technology and technological aptitude lead to sustained project success.

Place Your Trust in Ingenuiti

Life sciences regulations will continue to evolve worldwide. As a seasoned and specialized LSP in software localization for the life sciences industry, Ingenuiti offers accurate, high-quality regulatory localization services. We understand each region’s unique regulatory landscape and specialize in providing our clients with consistent, fully compliant software localization services.

Experience the difference Ingenuiti makes by placing your trust in an experienced LSP with a proven and successful track record in software localization.

Place your trust in Ingenuiti.


1 “Transforming Regulatory Strategy to Meet the Evolving Compliance Landscape.” Regulatory Affairs Professionals Society (RAPS)

2 PricewaterhouseCoopers. “25th Annual Global CEO Survey.” PwC.

³ “Center for Devices and Radiological Health. “Software as a Medical Device (SaMD).” U.S. Food and Drug Administration, FDA,

“Lex – 32017R0745 – En – EUR-Lex.” EUR.