NIST, NIH Seek Input on Future Medical Technology Measurement Standards
NIST and NIH seek public input on future medical technology measurement standards to help shape a federal roadmap for medical metrology.
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AAMI Reaches 15,000 Members Across Healthcare Technology Sectors
The association has more than doubled its membership since 2017, spanning medical device industry, sterilization, and healthcare technology management professionals.
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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.
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NIST, NIH Seek Input on Future Medical Technology Measurement Standards
NIST and NIH seek public input on future medical technology measurement standards to help shape a federal roadmap for medical metrology.
AdvaMed Calls for Medical Technology Exemption from Tariffs
AdvaMed is advocating for an exemption similar to that granted during President Trump’s first term to mitigate risks to patient care and US medtech innovation.
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FDA Adds AAMI Sterilization Guidance to Standards Database
FDA has recognized four AAMI sterilization documents in its Consensus Standards Database, including updated guidance on ethylene oxide usage.
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NFPA Proposes Reorganized National Electrical Code
NFPA is seeking industry feedback on reorganizing the 2029 National Electrical Code to address evolving technologies and terminology.
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AI Risks Tied to Technology Type and Healthcare Context
Paragon Health Institute’s new report urges context-specific AI regulation in healthcare, leveraging existing agencies, avoiding centralization, and balancing innovation with safety to protect public interests.
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Quest Expands Field Corrective Action Services for OEMs
Quest International has expanded its FCA services, offering medical device OEMs scalable solutions for regulatory compliance.
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ISS Solutions Achieves ISO 13485:2016 Certification
ISS Solutions has obtained ISO 13485:2016 certification, confirming its adherence to quality management standards for medical devices and ensuring their safety and reliability.
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ASHE Announces 2025 Advisory Board Election Results
ASHE announced the results of its 2025 Advisory Board election, appointing Dennis Ford as president-elect and several regional reps.
