MDCG 2024-2: Procedures for the Updates of the European Medical Device Nomenclature Published: March 13, 2024 View
WOUNDS UK: Models and Methods to Support the Development of Novel Burn Wound Antimicrobial Treatments Published: November 16, 2023 View
ANSI/AAMI ST98: A Guideline for Cleaning Validations of Reusable Devices Published: October 10, 2023 View
FDA Publishes Notice of Modifications to the Recognized Consensus Standards for Medical Devices Published: August 15, 2023 View
EU Commission Publishes MDR Implementing Regulation for Devices without Medical Purpose (Annex XVI) Published: December 6, 2022 View
First Manual on Borderline and Classification under MDR Published by the European Commission Published: September 13, 2022 View
New MDCG 2022-5 Guidance on Borderline between Devices and Drugs under MDR Published: May 9, 2022 View
FDA Announces Release of “FDA Guidance: Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions” Published: January 31, 2022 View
FDA Releases Final Guidance on Bone Anchor Premarket Notification 510(k) Submissions Published: March 5, 2020 View
The Evolution of the Accreditation Scheme for Conformity Assessment (ASCA) for Medical Device Premarket Approval Published: December 3, 2019 View