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Get the latest global medical device regulatory news, insights from our experts, and more.

Apr ,04 2019

Top 5 issues for medical device risk management and design controls

EMERGO BY UL SUMMARY OF KEY POINTS: A medical device’s
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Apr ,03 2019

US FDA identifies hundreds of device types affected by sterilization facility closures

EMERGO BY UL SUMMARY OF KEY POINTS: US FDA identifies
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Apr ,01 2019

Japanese regulators increase medical device registration fees for 2019

EMERGO BY UL SUMMARY OF KEY POINTS: Japan’s PMDA has
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Apr ,01 2019

Latest insights on FDA expectations from the HFES Health Care Symposium

EMERGO BY UL SUMMARY OF KEY POINTS: FDA reviewers emphasized
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Mar ,26 2019

US FDA targets safety of materials used in medical devices

EMERGO BY UL SUMMARY OF KEY POINTS: FDA plans closer
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Mar ,22 2019

Brexit delay: Reduced risk of no-deal withdrawal for medical device manufacturers?

EMERGO BY UL SUMMARY OF KEY POINTS: No Brexit on
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Mar ,21 2019

Applying human factors to nicotine replacement therapy drug products

EMERGO BY UL SUMMARY OF KEY POINTS: US regulators reevaluating
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Mar ,21 2019

Dutch regulators weigh in on no-deal Brexit impact for medical device companies

Currently Brexit is planned on 29 March 2019, but it
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Mar ,18 2019

FDA issues final guidance on devices containing animal-derived materials

EMERGO BY UL SUMMARY OF KEY POINTS: FDA has issued
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Mar ,14 2019

Fatal Medical Error: Too common to investigate thoroughly?

EMERGO BY UL SUMMARY OF KEY POINTS: Investigations of preventable
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Mar ,13 2019

Australian medical device regulators preparing Brexit contingency plans

EMERGO BY UL SUMMARY OF KEY POINTS: The Australian TGA
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Mar ,12 2019

Increased requirements for clinical evidence under the new Medical Devices Regulation (MDR)

EMERGO BY UL SUMMARY OF KEY POINTS: European MDR clinical
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Mar ,07 2019

Italian medical device nomenclature to be adapted for Eudamed database

EMERGO BY UL SUMMARY OF KEY POINTS: The European Medical
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Mar ,07 2019

US, Canadian regulators warn of potential medical device shortages following Sterigenics shutdown

EMERGO BY UL SUMMARY OF KEY POINTS: The shutdown of
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Mar ,05 2019

Brazil's ANVISA launching Notification pathway for low-risk medical devices and IVDs

EMERGO BY UL SUMMARY OF KEY POINTS: Brazilian regulators have
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