Whether you’re producing medical devices within Europe or supplying to Europe, as a manufacturer or supplier, you will need to adhere to the new EU MDR.
The European medical device industry is a third of the way into a 3-year transitional period that will culminate with full implementation of EU MDR.
The European medical device industry is in the grip of the biggest changes the market has seen in decades.
Global clinical trials labeling can be a complex subject and is an integral part of clinical trials supplies management. The landscape is varied in terms of the systems and processes employed in designing, populating and printing labels – including booklets and instructions for use (IFUs).
The continual tightening of regulation around the packaging and labeling of medical devices has so far failed to stimulate a transformation of labeling infrastructure and approach among global device manufacturers.
An examination of UDI implementation and lessons for manufacturers of Class II device. Almost two and a half years after the FDA issued its final rule on a Unique Device Identification system, the clock is ticking relentlessly towards the next critical deadline in the timetable for its compulsory introduction
How leveraging supplier validation capabilities can help transform the validation cycle and drive progress, productivity and profitability.
The introduction of Unique Device Identification (UDI)regulations signals a seismic shift in theMaintaining an efficient supply chain is widely acknowledged as a key strategic imperative for businesses across the global life science sectors.
The introduction of Unique Device Identification (UDI)regulations signals a seismic shift in the labeling of medical devices. Over the past twenty years, the development of labeling solutions for the highly regulated devices sector…
An Introduction to The Challenges Presented By Product Codification & Serialization In The Pharmaceutical Sector