The FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants; Requests Allergan Voluntarily Recall Certain Breast Implants and Tissue Expanders from…
Posts published in July 2019
MHRA guidance updated to reflect the MDR – Clinical investigations of medical devices – Biological safety assessment
Draft ANSM’S GUIDELINE Cybersecurity of medical devices integrating software during their life cycle
ANSM’S GUIDELINE Cybersecurity of medical devices integrating software during their life cycle
BSI – ISO 13485 and products with May 2020 deadline for MDR certification
TGA – Medical device cyber security guidance for industry
Medicines and Healthcare Products Regulatory Agency Annual Report and Accounts 2018 to 2019
Digital Health Update: Mid-Year Update on Software Precertification Program
Dental radiographic X-ray imaging: dose to patients
Programmable CSF Shunts and Magnetic Field Interference with Implanted Hearing Devices – Letter to Health Care Providers
MHRA launches consultation on how to best engage patients and the public