Good Machine Learning Practices for Medical Devices
In 2021 Health Canada, the U.S Food and Drug Administration (FDA), and the United Kingdom’s Medicines and Healthcare products Regulatory…
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MDCG 2022-13 Updated Guidance on Notified Bodies
The current guidance document regarding MDCG 2022-13 Rev. 1 Designation, Re-Assessment and Notification of Conformity Assessment Bodies and Notified Bodies…
New SCHEER Guidelines on Phthalates for Medical Devices
In 2019 the SCHEER (Scientific Committee on Health, Environmental and Emerging Risks) Guidelines on the benefit-risk assessment of the…
EU Regulatory Importer Requirements for Medical Device Software (MDSW)
While the MDCG has worked extensively on building up the library…
MDCG Surgical Mesh Implants Guidance
The Medical Device Coordination Group (MDCG) has published a new guidance document on Vigilance System for…
FDA AI Program: AI/ML Medical Device Research
The FDA’s AI Program in the Center for Devices and Radiological Health conducts regulatory science research to…
FDA Announces eMDR System Updates
The FDA has announced updates to the CDRH’s Electronic Medical Device Reporting (eMDR) system. These updates are crucial for…
Swiss Economic Operator Vigilance Requirements Under IvDO
With the establishment of…
Swissmedic: Reporting Serious Events for Medical Devices & IVDs
Swissmedic recently unveiled an insightful video that underscores the critical nature of reporting serious…
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