Introduction In January 2024 the European Commission decided to delay some elements of IVDR. But, to protect patient care and safety they at the same time agreed to speed up the launch of some parts of the European Database on Medical Devices (EUDAMED). What Is EUDAMED EUDAMED is the IT system established by IVDR, and … Learn More
Introduction The European Union Medical Device Regulation (MDR) adopted in April 2017, changed the European legal framework for medical devices and introduced new principal and supportive responsibilities for EMA and for national authorities in the assessment of certain categories of medical products. The aim of the MDR is to ensure patient safety and provide greater transparency and traceability … Learn More
The impact of language errors in clinical trials can be significant, leading to confusion for the participants and researchers. These frustrating events can lead to dropouts, delays in execution timelines, and even affect the validity of the ultimate trial results. Because of this, regulatory agencies now require that global clinical trials are accurate, consistent, and culturally appropriate in each of the local countries they are administered.
Investing in high-quality transcreation services can be a major differentiator for a successful clinical trial, by ensuring regulatory compliance and improved patient outcomes.
What is The GDPR? The General Data Protection Regulation (GDPR) is an EU regulation that sets more stringent rules to improve data protection and privacy for all individuals residing within the European Union. GDPR was approved on 24 May 2016, and gives all organizations until 25 May 2018 to fully comply with the new legislation. Does … Learn More
After over 40 years of negotiating, a single European patent system has been developed that makes protecting intellectual property (IP) easier, more efficient and cost effective. This new system will grant one patent to cover the 25 countries that are joining and endorsing the new system. This Unified European Patent system reduces translation requirements and maintenance … Learn More
This year Croatia becomes the 28th EU member state to require CE Marking. This means that manufacturers will be able to place products, devices and machines on the Croatian market, but those items must have documentation in the Croatian language. After reading the above sentence you may find yourself asking, “what is CE marking, and what … Learn More
On October 1, 2012 the US Federal Transit Administration (FTA) and Department of Transportation (DOT) finalized and released Circular 4702.1B which clarifies and explains guidelines for Title VI language and translation requirements. Previously the DOT language requirements were confusing. Some transportation agencies did not understand that the language requirements applied to them. To address the … Learn More
This blog on Pharmacy Language Requirements rightfully belongs to our subsidiary RxTran, but since our CEO Brian Kratt is standing today to deliver a presentation on nationwide pharmacy language laws and options for pharmacies to offer language services, I thought it only right to make it my blog topic. Increasingly, pharmacies recognize the mandates to … Learn More
There is a debate about bringing the language of Informed Consent Forms (ICFs) down to a level that is more universally understandable. If English speakers struggle to understand the language of Informed Consent Forms, imagine the difficulty that exists for people with limited English proficiency (LEP). The US Food and Drug Administration (FDA) (21 CFR … Learn More
You may not have thought of it, but if you are localizing or translating your website and digital content, you may need to keep it Section 508 compliant. With over 20% of web users that have some disability, Section 508 compliance can help you reach up to 20% more of your target audience that you … Learn More