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Devicemakers seeking to market their products in Malaysia must submit a declaration of conformity with the country’s medical device requirements, including certification of their quality management system and a list of applicable standards, according to draft guidance issued in June. Read More
Following more than 5,000 complaints including reports of patient injuries and four deaths, the FDA is taking a second look at the safety and effectiveness of Bayer’s Essure birth control implant. Read More
As global outsourcing has made managing supply chains more difficult, a group of 12 devicemakers has taken matters into its own hands to develop a supplier accreditation program to ensure quality and to be a step ahead of FDA inspectors. Read More