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QMSR Central

Resources and services to prepare your business for the QMSR

QMSR Central

Welcome to QMSR Central: Your Trusted Source for FDA Quality Management System Regulation (QMSR) Guidance

At QMSR Central, we specialize in providing comprehensive information, resources, and services to help businesses seamlessly transition to the FDA’s Quality Management System Regulation (QMSR). Whether you’re a seasoned professional in the medical device industry or new to regulatory compliance, we’re here to guide you every step of the way.

Why the QMSR Matters

The FDA’s QMSR, which will replace the longstanding Quality System Regulation (QSR), aligns with international standards like ISO 13485 to modernize regulatory compliance for medical devices. This shift represents a significant opportunity for manufacturers to enhance their processes, ensure product quality, and maintain market access. And medical device manufacturers who market their  products in the United States (some Class I, most Class II, and all Class III) must comply with the QMSR starting February 2, 2026.

The primary concern for any healthcare product is patient safety. A quality system ensures that products meet stringent safety standards throughout the manufacturing process, from raw material sourcing to distribution. This helps mitigate the risk of harm to patients and reduces the likelihood of adverse events. 

Start Your QMSR Journey Today

Navigating the FDA’s QMSR doesn’t have to be overwhelming. With the right support and resources, you can achieve compliance efficiently and effectively. Explore our site to learn more about our services or contact us to schedule a free consultation.

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Have questions or need assistance? Reach out to us at:

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ISO 13485:2016 Design and Development

Clause 7.3 - Design and Development
Clause 7.3.1 - General
Clause 7.3.2 - Design and development planning
Clause 7.3.3 - Design and development inputs
Clause 7.3.4 - Design and development outputs
Clause 7.3.5 - Design and development review
Clause 7.3.6 - Design and development verification
Clause 7.3.7 - Design and development validation
Clause 7.3.8 - Design and development transfer
Clause 7.3.9 - Control of design and development changes
Clause 7.3.10 - Design and development files

The Latest QMSR Posts

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Overview of Changes

QMSR Info Request Form

Definitions

Affected Regulations and Standards

Assembling the Puzzle

Implementation Strategies

Small Manufacturers

ISO 13485:2016 Clauses

1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
5 Management responsibility
6 Resource management
7 Product realization
♦ 7.3 Design and development
♦ 7.4 Purchasing controls
8 Measurement, analysis & improvement

How We Can Help

QMSR Central is your destination for:

  1. Educational Resources
    • Blogs and articles explaining key QMSR concepts
    • Online or on-site training
    • Step-by-step guides to implementing QMSR requirements
    • FAQs to answer your most pressing questions
  2. Consulting Services
    • Quality system audits
    • Documentation review and updates (Quality Manuals, SOPs, etc.)
    • Gap analyses to identify compliance needs
    • QMSR establishment and compliance guidance
  3. Compliance Tools
    • Checklists for QMSR implementation
    • Templates for documentation
    • Updates on regulatory changes

Request QMSR Information