Preethi Philip

September 17, 2025

Preethi Philip

Meet the Team: Trudy Kunnen

At MedQAIR, we’re proud of the people who make our mission possible. Each team member brings a unique blend of

September 9, 2025

Preethi Philip

Meet the Team: Mike Graney

At MedQAIR, we combine regulatory expertise with a passion for building bridges, connecting continents, linking innovators with compliance, and uniting

SAHPRA Issues Regulatory Requirements for AIML-Enabled Medical Devices

September 2, 2025

Preethi Philip

SAHPRA Issues Regulatory Requirements for AI/ML-Enabled Medical Devices

The South African Health Products Regulatory Authority (SAHPRA) has published its first consolidated requirements for Artificial Intelligence and Machine Learning

Health Canada eSTAR Pilot Expanded - What Device Manufacturers Need to Know

August 28, 2025

Preethi Philip

Health Canada eSTAR Pilot Expanded: What Device Manufacturers Need to Know

Health Canada has expanded the scope of its electronic Submission Template And Resource (eSTAR) pilot, giving medical device manufacturers a

The Compliance Gap What Happens When Economic Operators Don’t Coordinate

July 22, 2025

Preethi Philip

The Compliance Gap: What Happens When Economic Operators Don’t Coordinate

Under the EU Medical Device Regulation (MDR) (EU) 2017/745 and In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746, compliance responsibilities are

EU AI Act Raises New Compliance Hurdles for Medical Devices

July 7, 2025

Preethi Philip

EU AI Act Raises New Compliance Hurdles for Medical Devices

The new EU Artificial Intelligence Act (AI Act, 2024/1689) adds a layer of regulatory requirements for medical device firms already

FDA Classifies Radiological Computer-Assisted Detection and Diagnosis Software to Class II

June 25, 2025

Preethi Philip

FDA Classifies Radiological Computer-Assisted Detection and Diagnosis Software to Class II

On June 13, 2025, the U.S. Food and Drug Administration (FDA) issued a pivotal final rule reclassifying radiological computer-assisted detection

MDCG 2025-5 New Q&A Clarifies Rules for IVD Performance Studies Under the IVDR

June 24, 2025

Preethi Philip

MDCG 2025-5: New Q&A Clarifies Rules for IVD Performance Studies Under the IVDR

On June 18, 2025, the EU Medical Device Coordination Group (MDCG) released MDCG 2025-5, a detailed Q&A document clarifying the

EU AI Act Key Implications for Healthcare and MedTech

June 18, 2025

Preethi Philip

EU AI Act: Key Implications for Healthcare and MedTech

A new paper titled “The AI Act: responsibilities and obligations for healthcare professionals and organizations,” published in Diagnostic and Interventional