validation

How Pharmaceutical Manufacturers Can Ease Labeling System Validation

Susan Gosnell Life sciences, Medical Devices, Pharmaceutical Leave a Comment

Imagine investing fifteen years or more in developing a promising new drug, only to have a simple labeling error derail your launch plans, or – even worse – result in a product being quarantined or recalled from the market. Unfortunately, this is not at all uncommon. FDA drug recalls are on the rise, increasing 65% over the last decade(Source: GS1), …

medical device and labeling and compliance

Addressing Medical Device Labeling & Compliance Challenges

Susan Gosnell Life sciences, Medical Devices Leave a Comment

The medical device industry is poised for growth in the coming years. This presents opportunities for many, but also immense challenges and greater strain on the supply chain. And considering that the medical device industry is highly regulated, these companies also have to pay special attention to varying requirements across borders, lengthy approval processes and non-compliance penalties – all of …

EU MDR

Five steps to EU MDR-compliant labeling

Susan Gosnell Life sciences, Medical Devices Leave a Comment

The EU MDR one-year delay gives you the opportunity to take a more measured, strategic approach to compliance. However, it’s important to use the time wisely. In this blog, we highlight five steps that will help you on the road to UDI compliance. We’ll also talk about how to review your existing labeling processes and ensure you’re using the best …