This course is based on the 2016 version of the ISO 13485 Standard, providing skills necessary to perform internal process audits in the medical device industry. It features a detailed review of the ...

efficient process control, and product traceability. “KeborMed's management has consistently demonstrated their unwavering commitment to ISO 13485 compliance across all areas of operations ...

“Maintaining ISO 13485 was the next step in the regulatory approval process, bringing HeartHero one step closer to CE Mark, FDA approval, and bringing Elliot to market. HeartHero also gives our ...

Aug. 21, 2024 (GLOBE NEWSWIRE) -- Today Cytek Biosciences, Inc. (Nasdaq: CTKB) announced that its San Diego reagent manufacturing facility has been awarded EN ISO 13485:2016 Quality Management ...