June 13, 2023 By Jim Hammerand FDA removes products from medical device shortage list, reports AED discontinuation
June 2, 2023 By Jim Hammerand 5 critical questions medical device manufacturers must ask potential lab testing partners
May 23, 2023 By Jim Hammerand Mexico Ministry of Health updates rules and requirements for medical device classification
May 1, 2023 By Jim Hammerand May 2023 edition: Endolumik’s big step for safety, ortho hot topics, SaMD development lessons
April 12, 2023 By Jim Hammerand EPA proposes new ethylene oxide rules for medical device sterilization
April 11, 2023 By Jim Hammerand FDA seeks volunteers for medical device radiation sterilization pilot
March 30, 2023 By Jim Hammerand FDA seeks feedback on pre-determined change control plans for AI/ML medical devices