by Devices and Pharma | 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...
by Devices and Pharma | 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®...
by Devices and Pharma | 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.
by Devices and Pharma | Dec 31, 2022 | Consumer Information, FDA Enforcement, FDA Public Information, Industry News, Med-Devices, Pharmaceuticals, Product-Innovation, Reg_Information, US-FDA
FDA Information - Conveniently Organized and Accessible Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Quickly find the FDA information you need Conveniently...
by Devices and Pharma | Dec 18, 2022 | Med-Devices, Reg_Information, US-FDA
The U.S. Food and Drug Administration (FDA) announced the issuance of its final guidance document for its template for electronic 510(k) submissions on September 22, 2022. The electronic Submission Template and Resource (eSTAR) electronic submissions template is a...
