Medical device manufacturers face the challenge of efficiently managing increasingly high volumes of data relevant to product labeling in a vast array of different forms.
The world of regulated label management has its share of highly specialized, technical language. This glossary is intended to give an overview of the most commonly used terminology, with links to further information to help bring you up-to-speed.
Annex VI EU No 536/2014 is a clinical trial regulation which will impose new labeling challenges to the industry.
Unique clinical trial labeling software has been evolving to help customers streamline operations and adapt to new production and supply models
Validation is essential to ensuring patient safety and the integrity of the data in your labeling system.
FDA 21 CFR Part 11 allows Medical Device and Life Science organizations to use electronic records and signatures in place of paper.
WHAT IS IT?
Good Manufacturing Practice (GMP) compliance is part of a quality system covering the manufacture and testing of medical devices, active pharmaceutical ingredients, diagnostics, foods and pharmaceutical products. GMP standards are concerned with both production and quality control.
EU Medical Device Regulations (EU MDR) became fully applicable, a year later than initially planne
In the last fifteen months both individuals and organizations have had to change their behaviors. It’s typically meant more activity being done remotely, requiring greater agility and pace to deliver against changing demand, with technology often being deployed to overcome the unique challenges the pandemic has posed.
The COVID-19 pandemic has increased pressures across the medical device and clinical trial industries. Flexibility throughout all aspects of the supply chain has never been more valuable.