EU Commission Publishes MDR Implementing Regulation for Devices without Medical Purpose (Annex XVI)
Published: December 6, 2022
View
Auditing a QMS According to ISO 13485
Published: November 28, 2022
View
FDA Releases Long-Awaited Final Guidance for Clinical Decision Support Software
Published: September 30, 2022
View
Digital Health Software Pre-Certification Update: Final FDA Report Revealed
Published: September 28, 2022
View
First Manual on Borderline and Classification under MDR Published by the European Commission
Published: September 13, 2022
View
MDCG 2022-14: Transition to the MDR and IVDR – Notified Body Capacity and Availability of Medical Devices and IVDs
Published: September 1, 2022
View
MDCG 2022-10: Interfaces between the Clinical Trial Regulation and IVDR
Published: August 15, 2022
View
MDCG 2022-3: Verification of Manufactured Class D IVDs in accordance to the IVDR—One Size Fits All?
Published: July 21, 2022
View
Navigating the 510(k) EO Sterility Change Master File Program
Published: June 29, 2022
View
MDCG 2022-8: Clarification of IVDR Requirements for Legacy Devices
Published: June 23, 2022
View
MDCG 2022-2: Recommended Strategies for Data Retrieval and Literature Reviews
Published: June 16, 2022
View
MDCG 2022-6: Transitional Provision Considerations for IVDR Conformity
Published: June 1, 2022
View
Utilization of Least Burdensome Principles during FDA Reviews Benefits Industry
Published: May 16, 2022
View
New MDCG 2022-5 Guidance on Borderline between Devices and Drugs under MDR
Published: May 9, 2022
View
The Repeal of MCIT: 3 Key Takeaways for Medical Device Manufacturers
Published: May 2, 2022
View
FDA Announces Optional Pathway for Clearance of Surgical Sutures
Published: April 13, 2022
View
