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: ISO 13485</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 […]
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 […]
Is that eQMS platform (such as SharePoint) fit for its purpose?
April 6, 2023 Is that eQMS platform (such as SharePoint) fit for its purpose? I saw a question today wondering whether SharePoint is suitable for maintaining a medical device QMS documents system and record control. In a nutshell, SharePoint (or whatever other eQMS practice is proposed) may or may not be suitable for maintaining […]
Regulatory Review of Marketing Literature and other DHF Elements
April 3, 2023 Regulatory Review of Marketing Literature and other DHF Elements Virtually all aspects of design and development are officially regulated activities, especially labeling/advertising development. Moreover, the quality management system demands that all personnel whose work can affect compliance shall be competent regarding their respective assignments. But even if sales and marketing (or other […]
ISO 13485: Design & Development Obligations of Contract Manufacturers
March 29, 2023 ISO 13485: Design & Development Obligations of Contract Manufacturers As a general rule, a contract manufacturer who doesn’t perform any design and development for the subject device is thereby not required to have design and development in the scope of that contract manufacturer’s ISO 13485 certificate. So its certificate scope statement […]
Problem Containment Actions for Controlling Regulatory Impact
March 21, 2023 Problem Containment Actions for Controlling Regulatory Impact Today I received a question wrestling with the fact that problem containment actions tend to primarily focus on product containment and patient impact/risk, while not so much on containment actions aimed at controlling regulatory risk. This reminds me of ISO 13485’s deliberate distinction between […]
Quality Agreements – Ownership and Format
March 13, 2023 Quality Agreements – Ownership and Format The Quality and/or Regulatory departments need to be the primary authors of the Quality Agreement. Yet the Quality Agreement nonetheless still needs to be corporately/legally executed between the parties. Thus, the signatories should be executive officers in order to assure the Agreement has the necessary […]
DHF Documentation of Design Changes
March 13, 2023 DHF Documentation of Design Changes Neither the FDA nor ISO 13485 mandate a required format for the Design History File (DHF). Accordingly, we have latitude to decide what structure, format, and organizational approach we use to meet the basic regulatory requirements and objectives for the DHF. Accordingly, if your system does […]