Electronic Health Reporter

OCTOBER 28, 2020

The CE mark we know and recognize today was originally an EC mark, but in 1993, this was replaced with the CE mark we use now, which is found in directive 93/68/EEC. This CE mark […]. This article is copyrighted strictly for Electronic Health Reporter. Illegal copying is prohibited.

103

103

SQA

MAY 24, 2023

ANVISA Resumes Inspections in the Area of Technovigilance, 29 March 2023 In partnership with local Health Surveillance, ANVISA technical teams carried out in March 2023 two (2) medical device manufacturer inspections with an aim to strengthen the monitoring of these products in Brazil, ensuring their safety, performance, and quality.

FDA 40

FDA Licensing Governance Compliance 40

SQA

OCTOBER 18, 2023

The inspection was motivated by complaints received by health surveillance agencies located in different Brazilian states, which reported on irregularities related to the composition of the companies’ products and divergences related to the labeling information of manufacturers and those responsible for the products.

FDA 40

FDA Compliance Licensing World Health 40