Tariffs Create Ripple Effects Across Medical Device Regulatory Pathways
Changes in suppliers and manufacturing locations to avoid tariffs can require new regulatory filings, increasing time and cost burdens across global markets.
Category: Regulations & Standards
Regulations & Standards
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Regulations & Standards
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WHO Introduces MeDevIS Platform for Medical Device Information
The WHO has launched MeDevIS, an online platform providing comprehensive information on medical devices to aid governments and regulators.
Regulations & Standards
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NIH Offers $2 Million for Fetal Diagnostic and Monitoring Solutions
The NIH will award up to $2 million in cash prizes to accelerate development of diagnostic and monitoring technologies for fetal health.
Regulations & Standards
Latest
Tariffs Create Ripple Effects Across Medical Device Regulatory Pathways
Changes in suppliers and manufacturing locations to avoid tariffs can require new regulatory filings, increasing time and cost burdens across global markets.
Vaccine Mandates for Healthcare Workers Gaining Momentum
A push for vaccination mandates for healthcare workers could affect those in the HTM field who work in healthcare facilities.
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FDA Hiring More Experts to Help Healthcare ‘Unleash the Power of Data’
Commissioner Hahn says the FDA is hiring the best people to analyze healthcare data to make better decisions and adapt as technology changes.
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CDRH Director Says Flexibility Key as COVID-19 Strains Regulatory System
Jeffrey Shuren says the regulatory structure for medical devices needs to change and adapt with lessons learned from the COVID-19 pandemic.
Read MoreWSO2 Launches Open Healthcare Solution
WSO2 Healthcare Solution provides a complete platform for fast-tracking API-driven compliance and digital business innovation.
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AAMI Releases Complete Collection of Modern Dialysis Standards
AAMI is releasing Complete Dialysis Collection: 2020 edition, a comprehensive collection of 14 dialysis standards. New editions of the book will be regularly released to keep pace with the rapidly changing dialysis landscape.
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What Are the Biggest Technology Challenges Facing Healthcare?
An MD and chief medical officer discusses the technology challenges of making information quickly available to doctors while maintaining HIPAA compliance.
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Regulations & Standards
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FDA Explains How EUA Medical Devices Can Electronically Comply with AE Reporting Requirements
The FDA has outlined the steps facilities using EUA medical devices should take to comply with AE reporting requirements electronically.
