Are you receiving conflicting information about language requirements as they apply to medical software? You are not alone! Some auditors are claiming that translating the User Interface (scripts) is NOT necessary per Directive 2007/47/EC. Many are puzzled by this statement as the March 21, 2010 deadline for Directive 2007/47/EC approaches. Excel Translations decided to ask an expert.
In this article, Excel Translations elicited the advice of Brian Ludovico who is senior technical manager and certification officer at TÜV Rheinland’s Boxborough, MA, office and manages the company’s CMDCAS program. Mr. Ludovico has 16 years of experience in the medical device industry, including four years at U.S. Surgical Corp. Most recently, he was a keynote presenter at the RAPS seminar “Racing to Ensure Compliance with the New EU Medical Device Directive Requirements-2010 Deadline!”
Choosing Your Medical Translation Partner. Know what you need to do to be compliant and avoid the risk of losing your CE Mark. With this comprehensive article you will learn the language requirements for software, review a case study and see what situation faced a US based medical device manufacturer, gain the perspective and position of a medical device industry expert with regards to the translation of software scripts, and understand the best next steps.