An FDA safety alert threatened to derail approval of a critical medical device, making flawless clinical data translation a mission-critical priority under intense regulatory pressure.
The Situation
A global medical device company was riding on the momentum of a successful European product launch: a next-generation orthopedic replacement system that promised improved patient outcomes and innovative design. The product had recently secured FDA pre-market clearance, a significant milestone that opened the door to the U.S. market and expanded patient access.
But just as commercialization began to scale, an unexpected FDA safety communication hit. Stopping them in their tracks. The device was flagged for a higher-than-expected risk of failure, which was devastating for a new MedTech offering launch overseas. The news sent ripples of concern through regulatory teams and executives alike. Market momentum stalled, and an urgent regulatory challenge emerged that could jeopardize U.S. access.
To respond, the company was tasked with submitting extensive supplemental clinical data to the FDA—data initially generated and stored in Switzerland. The documents were vast in number and diverse in format, mainly authored in Swiss German, but also containing Swiss French segments. There were no editable source files; only redacted PDFs peppered with handwritten notes and complex medical terminology. Every word needed to be meticulously translated, certified, and ready to meet the FDA’s rigorous standards and the submission deadline.
The Challenge
What initially seemed like a standard regulatory translation project rapidly became a multifaceted logistical and linguistic challenge.
The company’s clinical data arrived in phased batches, sometimes without advance notice, each containing a large quantity of source files, and over a hundred files, occasionally ballooning into hundreds of documents. Each batch was an urgent priority, requiring careful sequencing aligned with FDA submission deadlines.
Compounding the pressure, roughly 95% of the content was in Swiss German. Yet, midway through the project, translators discovered embedded sections of Swiss French that had not been flagged in initial assessments. The team needed to adjust swiftly, recruiting additional French-speaking specialists to maintain pace without compromising accuracy.
Adding complexity, all documents were provided as redacted, scanned PDFs, often containing illegible handwriting, inconsistent formatting, and sensitive medical details. The absence of source files meant our linguists had to fully reconstruct every document into clean, editable Word files, preserving medical terminology, confidentiality, and formatting integrity with no margin for error.
A significant hurdle emerged early on: discrepancies between the client’s master document list and the files delivered. Some critical files were missing while others were mistakenly included. This posed a considerable risk; translating the wrong documents or overlooking essential clinical data could derail the entire submission.
The client’s regulatory team, already stretched thin managing FDA communications and clinical operations, leaned on Morningside for translation, strategic triage, quality control, and operational clarity.
The Solution
From day one, Morningside, a Questel Company, positioned ourselves as a trusted extension of the client’s regulatory team, not just a language vendor.
Our project managers designed a dynamic, custom file-tracking system synced with the FDA’s submission phases. Every new batch was rigorously cross-checked against the master list. Missing or extraneous files were flagged immediately and addressed through close collaboration with the client’s CRO, avoiding costly translation errors or delays.
Our linguistic team, fluent in both Swiss German and Swiss French, handled nearly a million words of clinical content with surgical precision. We rebuilt each redacted PDF into an editable Word format, preserving formatting, annotations, and critical medical terminology. Medical-trained linguists carefully transcribed sensitive handwritten notes, ensuring no nuance was lost.
When the unexpected French content surfaced mid-project, we adapted seamlessly. Additional French-speaking translators were onboarded, workflows realigned, and delivery schedules recalibrated. The team maintained a rolling delivery cadence, prioritizing high-impact files so the client could begin FDA reviews without waiting for the entire batch.
When a batch arrived with multiple hand-annotated pages and newly discovered French sections, it was a curveball that would have stalled many teams. But our linguists dove in immediately, working around the clock alongside our global team of project managers to reconstruct, translate, certify, and deliver the files before the next morning’s regulatory checkpoint.
Every translation was delivered FDA-ready, certified, clean, and meticulously reviewed, allowing the client’s regulatory affairs team to submit confidently under intense scrutiny.
The Journey
This engagement, which lasted nearly two years, encompassed 13 overlapping translation phases, each compressed into fast-moving 4–6-week cycles. Deadlines shifted, priorities evolved, and the scope expanded, but the partnership endured.
What could have spiraled into a bureaucratic bottleneck became a fluid, collaborative operation where communication was constant, roles—precise, and trust—absolute. As one regulatory lead noted:
“Morningside didn’t just meet deadlines; they anticipated problems before we even saw them. Their proactive communication turned a high-stress situation into a manageable process. It felt like an entire in-house team was dedicated to our submission.”
Our teams responded to FDA feedback on the fly with synchronized handling of urgent requests and clarifying clinical terminology. Each new batch was met with the same rigor and care as the last, proving that quality and speed could coexist—even under extraordinary pressure.
By maintaining tight operational control and deep subject matter expertise, Morningside empowered the client to focus on its core mission: patient safety and regulatory compliance.
The Result
By project close, Morningside had:
- Translated nearly a million words of clinical data in Swiss German and Swiss French
- Fully reconstructed hundreds of redacted, handwritten medical files into FDA-ready deliverables
- Delivered on tight deadlines across 13 complex, overlapping project phases without a single critical error
- Enabled the client to respond to the FDA’s safety inquiry with confidence and clarity
Most critically, the company preserved U.S. market access for a life-changing medical device product, ensuring patients continued to receive advanced orthopedic care without interruption.
“This wasn’t just translation. It was damage control, submission strategy, and partnership. You helped us stay in the fight—and come out stronger.”
— Regulatory Affairs Lead, Global Medical Device Manufacturer
The Partnership
What began as a reactive, crisis-driven engagement became a long-term collaboration built on reliability and mutual respect.
When FDA requests for additional evidence arose a year later, the client returned to Morningside—not out of necessity but out of choice. They knew our team would deliver stability, accuracy, and high-touch, specialized project management when it mattered most.
About Morningside
At Morningside, a Questel Company, we support more than 4,000 clients in 55 countries. We provide end-to-end language solutions across pharma, biotech, medical devices, and healthcare—guiding products safely from patent to post-market.
Our services include clinical translation and validation, regulatory submissions for FDA, EMA, CFDA, and PMDA, medical interpretation and content commercialization. Every project benefit from our unwavering commitment to quality, leveraging certified subject matter experts, ISO-compliant processes ensure consistent excellence.
Our industry-leading client platform offers 24/7 transparency and control over project timelines and spend, paired with dedicated white-glove support from specialized Life Sciences project managers.
With over 20 years of experience, Morningside is your trusted partner for navigating the complex linguistic and regulatory challenges of the life sciences industry.
We don’t just translate. We protect your path to commercialization.
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