DITTA White Paper on Cybersecurity: Best Practices in the Medical Technology Manufacturing Environment
Posts published in February 2019
New report from the National Institute for Public Health and the Environment – RIVM from the Netherlands – Apps under the medical devices legislation
Interesting discussion on this important topic – Summary International Expert Meeting on breast implant-associated lymphoma
MDCG 2018-8 – Guidance on Content of the certificates, voluntary certificate transfers
Nonbinding Feedback After Certain FDA Inspections of Device Establishments
Topics to be discussed: breast implant associated anaplastic large cell lymphoma (BIA-ALCL); systemic symptoms reported in patients receiving breast implants; the use of registries for…
Consultation: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices
Consultation: Regulation of software, including Software as a Medical Device (SaMD)
Interesting reads regarding a surgical mesh (in particular in view of the recent discussion on the Bleeding Edge and Implant files): 2019 Meeting Materials of…
Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements