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FDA Posts Warning Letter to MicroVention Costa Rica 

by Bruce Waldon | Mar 1, 2023 | Alerts, FDA Enforcement, FDA Warning letters, Industry News, Med-Devices, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Identifies several violations of the FD&C Act and QSR  On February 7, FDA issued a warning letter it had sent to...

FDA Issues Letter to Warn of Abbott Trifecta Valve Risks 

by Bruce Waldon | Mar 1, 2023 | Alerts, Consumer Safety, FDA Public Information, Industry News, Med-Devices, Product Safety, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Letter outlines risks associated with the heart valve  On February 27, the FDA released a letter to healthcare...

FDA Announces Recall of GE Nuclear Medicine Systems 

by Bruce Waldon | Feb 26, 2023 | Alerts, Alerts-Device, Class I Recalls, Consumer Safety, Industry News, Med-Devices, MedWatch-System, Product Recalls, Product Safety, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact 1200-pound Devices Could Fall on Patients On February 15, the FDA issued a statement announcing a recall of certain...

FDA announces recall of LivaNova LifeSPARC System 

by Bruce Waldon | Feb 12, 2023 | Alerts, Alerts-Device, Class I Recalls, Med-Devices, MedWatch-System, Product Recalls, US-FDA

FDA Announces Recall of LivaNova LifeSPARC System Home About Consumer Medical Devices New Devices Safety Alerts Warning Letters Pharma New Drug Approvals Drug Shortages Safety Alerts Warning Letters Regulatory Services 510(k) Submissions Documentation News Enforcement...

FDA Approves Sentimag Magnetic Localization System for Biopsies 

by Bruce Waldon | Jan 4, 2023 | Industry News, Med-Devices, New devices, Product-Innovation, US-FDA

Home About Consumer Medical Devices New Devices Safety Alerts Warning Letters Pharma New Drug Approvals Drug Shortages Safety Alerts Warning Letters Regulatory Services 510(k) Submissions Documentation News Enforcement Alerts Innovation Contact Magtrace® and Sentimag®...

Regulatory Documentation for National and Global Market Access 

by Bruce Waldon | Jan 3, 2023 | EU MDR, FDA Approvals, FDA Regulations, Global-RA, Med-Devices, Pharmaceuticals, Reg_Information

With a solid base of technical documentation, our regulatory specialists will prepare a regulatory submission that is organized, well written, complete, and meets the regulatory requirements of the agency that will evaluate the product.

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