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The FDA slapped Houston, Texas-based Trilliant Surgical with a five-item FDA-483 that highlighted numerous lapses in corrective and preventive actions following an inspection covering Jan. 16, 2015 to Feb. 12, 2015. Read More
South Korean devicemaker Nuga Medical received an FDA warning letter related to a host of GMP woes, including design control and CAPA procedures. Read More
Failure to properly record complaint investigations and document evaluations of potential suppliers brought an FDA warning letter to a New Jersey manufacturer of filtration systems. Read More
The FDA slapped a warning letter on a California manufacturer of balloon catheters and inguinal hernia implants for not adequately evaluating complaints to determine device failure. Read More
A recent survey showing that device company executives are often unaware of problems faced by their quality control units may point to an overlooked contributing factor in FDA warning letters, an expert says. Read More
With a number of attempted and successful cyberattacks making headlines, what steps can medical devicemakers take to ensure the security of their products? Read More
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including certification of their quality management system and a list of applicable standards, according to draft guidance issued in June.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