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QMSR Compliance Timeline: How to Prepare Before FDA Enforcement Begins
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QMSR Compliance Timeline: How to Prepare Before FDA Enforcement Begins

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Health Canada Clarifies Device Licence Requirements for Diagnostic Ultrasound Systems
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Health Canada Clarifies Device Licence Requirements for Diagnostic Ultrasound Systems

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Implications for Medical Device & IVD Clinical Evidence Strategy
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Implications for Medical Device & IVD Clinical Evidence Strategy

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Importing and Supplying Medical Devices in Australia: What the January 2026 TGA Update Means for Manufacturers and Sponsors
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Importing and Supplying Medical Devices in Australia: What the January 2026 TGA Update Means for Manufacturers and Sponsors

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FDA Final General Wellness Policy: What It Means for Health Tech Companies
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FDA Final General Wellness Policy: What It Means for Health Tech Companies

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FDA Class I Recall Highlights Critical Packaging and Sterility Compliance Gaps
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FDA Class I Recall Highlights Critical Packaging and Sterility Compliance Gaps

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FDA Eliminates a Major Barrier to Using Real-World Evidence in Drug and Device Reviews
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FDA Eliminates a Major Barrier to Using Real-World Evidence in Drug and Device Reviews

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FDA’s ASCA Program: Driving Predictability in Standards-Based Medical Device Testing
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FDA’s ASCA Program: Driving Predictability in Standards-Based Medical Device Testing

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FDA Introduces TEMPO Pilot to Accelerate Digital Health for Chronic Diseases
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FDA Introduces TEMPO Pilot to Accelerate Digital Health for Chronic Diseases

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Windows 10 End-of-Support: What Medical Device Manufacturers Must Know
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Windows 10 End-of-Support: What Medical Device Manufacturers Must Know

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TGA Launches EU MDR Transition Web Publication Service: What Manufacturers Need to Know
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TGA Launches EU MDR Transition Web Publication Service: What Manufacturers Need to Know

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EU Launches Pilot Coordinated Assessment Program for CI/PS: What Medical Device Sponsors Need to Know
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EU Launches Pilot Coordinated Assessment Program for CI/PS: What Medical Device Sponsors Need to Know

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FDA Issues Revised Pre-RFD Guidance: What Industry Needs to Know
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FDA Issues Revised Pre-RFD Guidance: What Industry Needs to Know

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FDA Issues Draft Guidance on QMSR Information for Premarket Submissions
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FDA Issues Draft Guidance on QMSR Information for Premarket Submissions

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Notified Bodies Warn Shortage Could Hinder AI Regulation
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Notified Bodies Warn Shortage Could Hinder AI Regulation

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MHRA Plans Risk-Proportionate AI and Medical Device Oversight
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MHRA Plans Risk-Proportionate AI and Medical Device Oversight

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MedTech Industry Urges Comprehensive Reforms to MDR and IVDR
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MedTech Industry Urges Comprehensive Reforms to MDR and IVDR

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FDA Seeks Feedback on Real-World Performance of AI Medical Devices
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FDA Seeks Feedback on Real-World Performance of AI Medical Devices

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FDA’s ASCA Program: Transforming Medical Device Compliance
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FDA’s ASCA Program: Transforming Medical Device Compliance

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QMSR Final Rule Issued by FDA with 2-years Transition Period
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QMSR Final Rule Issued by FDA with 2-years Transition Period

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FDA Issues First Mass Drug Imports To States From Canada
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FDA Issues First Mass Drug Imports To States From Canada

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QMSR Compliance Timeline: How to Prepare Before FDA Enforcement Begins
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QMSR Compliance Timeline: How to Prepare Before FDA Enforcement Begins

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Health Canada Clarifies Device Licence Requirements for Diagnostic Ultrasound Systems
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Health Canada Clarifies Device Licence Requirements for Diagnostic Ultrasound Systems

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Thermal Management and Bio-Safety of High-Power Laser-Based Medical Devices
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Thermal Management and Bio-Safety of High-Power Laser-Based Medical Devices

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Implications for Medical Device & IVD Clinical Evidence Strategy
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Implications for Medical Device & IVD Clinical Evidence Strategy

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Failure Mode Patterns in MEMS Pressure Sensors under Sterilization and Long-Term Use
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Failure Mode Patterns in MEMS Pressure Sensors under Sterilization and Long-Term Use

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Importing and Supplying Medical Devices in Australia: What the January 2026 TGA Update Means for Manufacturers and Sponsors
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Importing and Supplying Medical Devices in Australia: What the January 2026 TGA Update Means for Manufacturers and Sponsors

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Latest Portfolio

FDA quality management system regulation impact on medical device manufacturers.

QMSR Compliance Timeline: How to Prepare Before FDA Enforcement Begins
Medical device regulatory documentation for ultrasound systems

Health Canada Clarifies Device Licence Requirements for Diagnostic Ultrasound Systems
Thermal simulation heat map of a high-power laser medical device heat sink and in-tissue thermal measurement during dermatologic treatment

Thermal Management and Bio-Safety of High-Power Laser-Based Medical Devices
UK clinical trial reform enabling faster medical device and IVD studies

Implications for Medical Device & IVD Clinical Evidence Strategy
Cross-section of MEMS pressure sensor package showing micro-crack initiation after sterilization

Failure Mode Patterns in MEMS Pressure Sensors under Sterilization and Long-Term Use
Importing and supplying medical devices under Australian TGA regulations

Importing and Supplying Medical Devices in Australia: What the January 2026 TGA Update Means for Manufacturers and Sponsors
Medical device signal waveform with AI interpretability feature attribution overlay

Explainable AI in Medical Device Signal Processing: A Validation Framework
FDA General Wellness Policy impact on health wearable devices and wellness applications

FDA Final General Wellness Policy: What It Means for Health Tech Companies
Medical device calibration rig showing sensor measurement and uncertainty analysis in metrology laboratory

Statistical Validation of Measurement Uncertainties in Medical Device Metrology
FDA Class I medical device recall highlighting regulatory compliance and patient safety risks

FDA Class I Recall Highlights Critical Packaging and Sterility Compliance Gaps
Microfluidic channel with modified surface showing enhanced wettability and reduced protein adsorption

Advances in Microfluidic Channel Surface Modification for Enhanced Bio-compatibility
FDA regulatory review process enhanced by real-world evidence data

FDA Eliminates a Major Barrier to Using Real-World Evidence in Drug and Device Reviews
Tissue-mimicking phantom block with embedded targets used for ultrasound/photoacoustic imaging validation

Design and Validation of Phantoms for Medical Imaging Devices
ASCA program workflow showing standards selection, accredited lab testing, and predictable FDA review

FDA’s ASCA Program: Driving Predictability in Standards-Based Medical Device Testing
Electrochemical biosensor baseline drift and noise correction graph

Noise Reduction and Drift Compensation in Electrochemical and Optical Biosensors

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