FDA Regulations - Medical Devices and Pharma

Quality Management System Regulation – QMSR

by DevicesandPharma | Apr 21, 2024 | FDA Regulations, Industry Information, Industry News, Med-Devices, Product Quality, Quality Information, Reg_Information, US-FDA

Understanding the New QMSR Impact of the FDA's QMSR on Medical Device Regulations Explore how the FDA’s newly introduced Quality Management System Regulation (QMSR) is set to redefine compliance standards in the medical device industry, transitioning from the...

FDA Quality System Regulation – 21 CFR 820

by DevicesandPharma | Apr 18, 2024 | FDA Regulations, Med-Devices, US-FDA

FDA Quality System Regulation (QSR) Regulations for medical device quality systems Home About Consumer Medical Devices Pharma AI Regulatory Quality News Enforcement Alerts Innovation My Account Contact FDA Quality System Regulation – 21 CFR 820 21 CFR 820, also known...

Regulatory Documentation for National and Global Market Access

by DevicesandPharma | 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.