January 2, 2026 FDA QMSR: More than Meets the Eye. Are You Ready? Introduction: FDA’s new Quality Management System Regulation (QMSR) is nearly upon us. The QMSR replaces the current Quality System Regulation (QS Regulation). Specifically, after a generous two-year transitional period, the QMSR becomes effective in just a few weeks on […]
<h1 class="entry-title">Category: QMS</h1>
MDSAP QMS Internal Auditing Must Verify Regulatory Compliance
November 24, 2025 MDSAP QMS Internal Auditing Must Verify Regulatory Compliance If an organization performs internal auditing only to its SOPs but not also to check the SOPs’ and the organization’s regulatory compliance, then it would be in violation of MDSAP’s requirements for internal auditing. Such an approach would, upon discovery, result in […]
FDA’s QMSR Final Rule Issued
January 31, 2024 FDA’s QMSR Final Rule Issued FDA has issued its Final Rule on its new Quality Management System Regulation (QMSR) amending its device current good manufacturing practice (CGMP) requirements of the 1996 Quality System (QS) regulation (21 CFR Part 820) to harmonize and modernize it primarily by incorporating by reference ISO […]
Notifying Your European Notified Body About Non-Significant Changes
January 11, 2024 Notifying Your European Notified Body About Non-Significant Changes Europe’s Union MDR (Regulation 2017/745) includes legislative authority (e.g., in Annex VII sec. 4.9) for Notified Bodies (NBs) to require a manufacturer to notify the NB about certain kinds of changes [e.g., QMS, product range, device design (including labeling), intended use or […]
External Documents Kept on an Externally-Controlled Server
April 21, 2023 External Documents Kept on an Externally-Controlled Server I know of no regulations or standards specifically demanding an “internal” copy of standards or country regulations. Instead, the logistics of this are generally left to our discretion. I elaborate further below. Let’s start with ISO 13485 / EN ISO 13485 (as amended […]