Due to Covid-19, on 17th April 2020, the European Parliament gave Medical Device companies a 12-month reprieve on EU MDR.
Companies’ continued reliance on manual processes and disparate labeling systems often culminates in pricey product recalls.
Global clinical trials labeling can be a complex subject and is an integral part of clinical trials supplies management.
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.
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…
FDA 21 CFR Part 11 allows Medical Device and Life Science organizations to use electronic records and signatures in place of paper. This helps organizations reduce the cost of managing and documenting their entire labeling lifecycle, from routing and approval workflow, version control and comparison, to audit trails and reports.