Tag: remanufacturing

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Understanding FDA’s Latest Rules on Medical Device Maintenance

The FDA's new guidance distinguishes between servicing and remanufacturing of medical devices, urging vigilance and regulatory adherence.

FDA Final Guidance Clarifies Medical Device Remanufacturing
Update: Advocates Stall Effort to Undermine Medical Right to Repair
MITA Applauds Legislation Regarding Medical Device Remanufacturing
FDA Extends ‘Remanufacturing’ Guidance Comment Period
FDA Issues Draft Guidance on Remanufacturing, Seeks Feedback on Cybersecurity Servicing of Medical Devices
FDA Sends Device Remanufacturing Draft Guidance to White House for Review

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COVID-19 Has Been a Mixed Blessing for Makers of Medical Equipment

The COVID-19 pandemic has had a huge impact on medical equipment manufacturers, with quickly shifting extreme highs and lows in revenue, reports the Economist.

‘Servicing’ Vs. ‘Remanufacturing’ Takes Center Stage
FDA to Host Public Workshop to Differentiate Between Servicing and Remanufacturing

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Understanding FDA’s Latest Rules on Medical Device Maintenance

The FDA's new guidance distinguishes between servicing and remanufacturing of medical devices, urging vigilance and regulatory adherence.

FDA Final Guidance Clarifies Medical Device Remanufacturing
Update: Advocates Stall Effort to Undermine Medical Right to Repair
MITA Applauds Legislation Regarding Medical Device Remanufacturing
FDA Extends ‘Remanufacturing’ Guidance Comment Period
FDA Issues Draft Guidance on Remanufacturing, Seeks Feedback on Cybersecurity Servicing of Medical Devices
FDA Sends Device Remanufacturing Draft Guidance to White House for Review

Tag: remanufacturing

All

Understanding FDA’s Latest Rules on Medical Device Maintenance

FDA Final Guidance Clarifies Medical Device Remanufacturing

Update: Advocates Stall Effort to Undermine Medical Right to Repair

MITA Applauds Legislation Regarding Medical Device Remanufacturing

FDA Extends ‘Remanufacturing’ Guidance Comment Period

FDA Issues Draft Guidance on Remanufacturing, Seeks Feedback on Cybersecurity Servicing of Medical Devices

FDA Sends Device Remanufacturing Draft Guidance to White House for Review

All

COVID-19 Has Been a Mixed Blessing for Makers of Medical Equipment

‘Servicing’ Vs. ‘Remanufacturing’ Takes Center Stage

FDA to Host Public Workshop to Differentiate Between Servicing and Remanufacturing

All

Sorry, No Posts Found

All

Understanding FDA’s Latest Rules on Medical Device Maintenance

FDA Final Guidance Clarifies Medical Device Remanufacturing

Update: Advocates Stall Effort to Undermine Medical Right to Repair

MITA Applauds Legislation Regarding Medical Device Remanufacturing

FDA Extends ‘Remanufacturing’ Guidance Comment Period

FDA Issues Draft Guidance on Remanufacturing, Seeks Feedback on Cybersecurity Servicing of Medical Devices

FDA Sends Device Remanufacturing Draft Guidance to White House for Review

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