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International medical device regulators are trying to entice more companies to participate in a single-audit pilot program, promising they will receive no warning letters unless the issues pose an immediate threat to public health. Read More
The FDA has unveiled a broad plan that will change the way it inspects devicemakers, handles recalls, issues and reviews enforcement decisions and screens imports, with companies likely to start feeling the impact by the end of 2015. Read More
Consolidation of the orthopedics devices space continued Oct. 27 as Wright Medical announced plans to merge with Tornier. The all-stock transaction has a combined value of approximately $3.3 billion. Read More
The Australia government plans to fast-track approvals of promising new medical technologies and conduct joint reviews with trusted foreign regulators as part of a broad effort to streamline the country’s device approval process. Read More