Skip to main content
search
Category

Industry Newsletters Regulatory Affairs Newsletter

FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveIndustry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Consensus Standards

FDA have updated the consensus standards- as at 26/05/2025. For the degree of recognition click on the recognition information column - Recognized Consensus Standards: Medical Devices This includes many CLSI updates for IVDs including some software aspects. Below are just the IVD updates. 05/26/2025 InVitro Diagnostics 7-328 Partial CLSI M100 35th Edition Performance Standards for Antimicrobial Susceptibility Testing   05/26/2025…
Ben Kemp
June 9, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

MDSAP Website

MDSAP have launched their refreshed website providing information on the Medical Device Single Audit Program. Official members include TGA Australia, ANVISA, Brazil, Health Canada, PMDA Japan, and US FDA, With the EU, HSA Singapore, MHRA UK, and WHO having joined as official observers, and ANMAT Argentina, Israel’s Ministry of Health, Kenya’s Pharmacy and Poisons Board, Republic of Korea Ministry of…
Ben Kemp
May 28, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveOther Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

NHS Transformation Bulletin – May 2025

Standardising Preoperative Urine Testing in Urology GIRFT has released a second guide in its preoperative testing series, focused on delivering a standardised approach to screening, managing, and treating urinary infections prior to elective urology surgery. Developed by GIRFT’s anaesthetic and perioperative medicine (APOM) clinical and nursing leads, the guide is aimed at clinicians and managers who work across the elective pathway…
Ben Kemp
May 15, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CLSI EP32 2 Ed

CLSI have updated EP32 Metrological Traceability to align with ISO 17511: https://www.linkedin.com/posts/clsilabnews_out-now-is-clsi-ep32-implementation-of-metrological-activity-7326236959385821184-v66f?utm_source=share&utm_medium=member_desktop&rcm=ACoAAAAeH9EBFpe2TIKx6c7gKShKVeAb46UjtpM
Ben Kemp
May 15, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

BSI IVDR Documentation Submission guide

BSI have added a section on AI/ML documentation to their guidance on technical documentation submission: https://www.linkedin.com/posts/bsi-medical-devices_bsi-medical-devices-ivdr-documentation-activity-7325889686483202048-X1A1?utm_source=share&utm_medium=member_android&rcm=ACoAAAAeH9EBFpe2TIKx6c7gKShKVeAb46UjtpM
Ben Kemp
May 15, 2025
Close Menu