Bringing a new drug to market is time-consuming and costly, and generally takes 10 years and costs over $1 billion. The smallest lapse in labeling and packaging can jeopardize even the most well-planned submission. A proofreading and comparison software can help you get there faster, safer.
With implementation of TVT in its quality assurance department, New World Medical is achieving significant time savings. It now also plans to roll out the automated proofreading solution from Schlafender Hase across other parts of the company.
Medical Devices Regulation (MDR) updates represent a step towards higher labeling standards.
The new European Database on Medical Devices, known as EUDAMED, was originally scheduled to launch in May 2020,
Hey! Regulatory affairs professionals! The European Medicines Agency (EMA) has been using TVT, the Text Verification Tool® since 2004!
The regulation on medical devices 2017/745, widely known as the EU MDR, was released in May 2017 with regulation 2017/746 on in vitro diagnostics. EU MDR and regulation 2017/746 replaced Council Directive 93/42/EEC, also known as the Medical Device Directive (MDD), and Directive 98/79/EC on in vitro diagnostic medical devices.
The majority of medical device recalls are due to labeling or software - HMI issues. TVT can help keep you from becoming a statistic.
