Regulatory Authority Assessment Method for Recognition and Surveillance of Medical Device Conformity Assessment Bodies
Medical Device Expert News
FDA Issues Final Guidance on the 510(k) Third Party Review Program
Dear all Due to the moment, SQR Consulting is offering, exceptionally free of charge to manufacturers or importers of medical devices in Brazil, the service…
Prezados Devido ao momento, a SQR Consulting está oferecendo, excepcionalmente de forma gratuita para fabricantes ou importadores de dispositivos médicos, o serviço de compilação e…
Notification of a Body in the framework of a technical harmonization directive – CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
State of play of joint assessments of Notified Bodies in the medical device sector
FDA issues “Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Pandemic”
Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat
MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software