For medical device manufacturers entering the European market, understanding EU MDR translation requirements is essential for regulatory compliance. Regulation (EU) 2017/745, known as the Medical Device Regulation (MDR), sets requirements for the safety, performance, and market access of medical devices […]
Eleven times in 2025, the FDA wrote to a drug company to explain that its people did not appear to know how to do their jobs. Six of those letters cite the same short regulation, 21 CFR 211.25(a), which asks
Clinical trials depend on willing and engaged participants, yet participation can be demanding. Frequent site visits, complex study information, long consent forms, travel requirements, unfamiliar procedures, and language barriers can make trials difficult to navigate. Patient centricity addresses these challenges
As decentralized and hybrid clinical trials become more common, sponsors are using digital technologies to collect clinical outcome data. An eCOA clinical trial can capture patient and clinician information in real time, but implementing these solutions across multiple countries introduces
The Electronic Common Technical Document (eCTD) is the standard format used by pharmaceutical and biotechnology companies to submit regulatory applications electronically to health authorities. It organizes dossier content into a structured format that allows agencies to receive, validate, review, and
Clinical trial findings should be understandable to everyone, especially the patients who participate in the research. However, many trial documents are written for regulators and healthcare professionals, making them difficult for the public to interpret. As transparency and patient engagement
MDR compliance is essential for manufacturers seeking to market medical devices in the European Union. The European Union Medical Device Regulation (EU MDR 2017/745) sets strict requirements to ensure devices meet high standards for safety, performance, and quality throughout their
South Korea is one of Asia’s largest medical technology markets, offering significant opportunities for medical device manufacturers. However, before a device can be imported, marketed, or sold, it must meet the Korean medical device registration requirements set by the Ministry
As clinical trials become increasingly global, the need for accurate Clinical Outcome Assessments (COAs) translation continues to grow. Pharmaceutical companies and Contract Research Organizations (CROs) are conducting studies across multiple regions, requiring patient assessments to be available in different languages
As pharmaceutical companies, biotechnology firms, medical device manufacturers, and clinical research organizations (CROs) expand into global markets, the volume of multilingual content they must manage continues to grow. Clinical trial documentation, regulatory submissions, product labeling, patient education materials, software interfaces,
Across 30 European markets, the same newly approved medicine reaches about 86% availability in Germany but takes years longer to reach the slowest markets, often at a fraction of that coverage. Even the average launch delay, the gap between a
The world’s largest drug safety database, the WHO’s VigiBase, holds over 40 million adverse event reports contributed by more than 180 countries. The FDA’s FAERS system has accumulated over 28 million reports and receives more than 2 million new ones
