Is Your Product a Medical Device or a Borderline Product?
Is Your Product a Medical Device or a Borderline Product?
July 25, 2023
2
min read
FDA Updates Their CLIA Waiver Process
FDA Updates Their CLIA Waiver Process
July 20, 2023
1
min read
Breakthrough Devices Program Updates Device Designations Data and Marketing Authorizations List
Breakthrough Devices Program Updates Device Designations Data and Marketing Authorizations List
July 13, 2023
1
min read
LDTs and Oncology Companion Diagnostics Pilot Program – One More Step into FDA Regulating LDTs!
LDTs and Oncology Companion Diagnostics Pilot Program – One More Step into FDA Regulating LDTs!
June 29, 2023
5
min read
Comparing UK MHRA Standalone Software and IMDRF Software as Medical Device Guidance Documents
Comparing UK MHRA Standalone Software and IMDRF Software as Medical Device Guidance Documents
June 22, 2023
2
min read
MHRA: Standalone Software and Apps
MHRA: Standalone Software and Apps
June 8, 2023
4
min read
Advancing Healthcare Innovation: FDA Explores AI/ML in Drug Development and Devices
Advancing Healthcare Innovation: FDA Explores AI/ML in Drug Development and Devices
May 24, 2023
5
min read
FDA’s New Clinical Trial Guidance Allows you to Streamline!
FDA’s New Clinical Trial Guidance Allows you to Streamline!
May 4, 2023
3
min read
FDA “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry” Clinical Insight Paper
FDA “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry” Clinical Insight Paper
April 13, 2023
5
min read