FDA Regulations - Medical Devices and Pharma

QMSR Quality Management System Requirements

by Bruce Waldon | Feb 20, 2025 | FDA Regulations, ISO 13485, QMSR, QSR, Quality Management System, Quality system, US-FDA

QMSR Quality Management System Requirements ISO 13485 Clause 4 and FDA 21 CFR 820.10 Home Request Info QMSR Central QMSR FAQs ISO 13485 Transition Impact Integration Definitions FDA and ISO 13485 ISO 9000 Small Manufacturers Overview of QMSR Quality Management System...

Quality Management System Regulation – QMSR

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

Home Request Info QMSR Central QMSR FAQs ISO 13485 Transition Impact Integration Definitions FDA and ISO 13485 ISO 9000 Small Manufacturers QMSR Central Understanding the New QMSR Impact of the FDA's QMSR on Medical Device Regulations Explore how the FDA’s newly...

FDA Quality System Regulation – 21 CFR 820

by Bruce Waldon | 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 QMSR Central News Enforcement Alerts Innovation Newsletter Newsletter Signup Account Login Register Contact QMSR Central...

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.