# QualityHub

> Practical Compliance. Real-World Ready.

## Core Content

- [QHub Brief║From Training Records to Employee Competence: Understanding QMSR & ISO 13485 Expectations for Makers of Medical Devices](https://qualityhub.com/qhub-brief%e2%95%91from-training-records-to-employee-competence-understanding-qmsr-iso-13485-expectations-for-makers-of-medical-devices/): This QualityHub Expert Brief examines the evolution of training requirements for makers of medical devices, highlights key differences between FDA's former Quality System Regulation (QSR) and its current QMSR framework, and outlines practical considerations for maintaining compliance.
- [QHub White Paper║Strategically Optimizing CAPA Systems: Regulatory Expectations & Operational Excellence](https://qualityhub.com/strategically-optimizing-capa-systems-regulatory-expectations-operational-excellence/): This QualityHub Expert White Paper examines the regulatory foundations, operational principles, and implementation practices associated with effective CAPA systems within the medical device industry. Particular emphasis is placed on risk integration, root cause investigation methodologies, Verification of Effectiveness (VoE) expectations, statistical monitoring systems, CAPA governance, and organizational CAPA maturity under the FDA’s new QMSR framework.
- [QHub Insights║Making the Most of Mock Audits: How to Turn Practice Inspections Into FDA Readiness](https://qualityhub.com/qhub-insights%e2%95%91making-the-most-of-mock-audits-how-to-turn-practice-inspections-into-fda-readiness/): Mock audits should do more than verify compliance. QualityHub experts say manufacturers should use realistic, risk-based practice inspections that mirror the FDA's investigative approach, prepare employees at every level for investigator interactions, and test operational readiness from the parking lot to the inspectional “front room.” Companies that integrate mock audits into their ongoing quality programs rather than treating them as a last-minute exercise can uncover quality system weaknesses early, strengthen inspection readiness, and reduce regulatory risk.
- [FDA Clarifies Scope of New Human Factors Submission Guidance, Emphasizes Risk-Based Approach](https://qualityhub.com/fda-clarifies-scope-of-new-human-factors-submission-guidance-emphasizes-risk-based-approach/): During a July 22 Town Hall webinar, FDA officials said their new human factors guidance applies only to marketing submissions and doesn't change MedTech manufacturers' broader design control obligations under the QMSR and ISO 13485. The agency stressed that companies should continue applying risk-based human factors and usability engineering throughout product development, regardless of the amount of documentation included in an FDA submission.
- [QHub Brief║Interpreting FDA's QMSR Compliance Program: FDA Inspection Types & Corresponding Models](https://qualityhub.com/qhub-brief%e2%95%91interpreting-fdas-qmsr-compliance-program-fda-inspection-types-corresponding-models/): With the FDA’s regulatory change from QSR to QMSR for medical devices comes an update of the agency’s Compliance Program Manual (CPM) for the inspection of MedTech manufacturers. This QualityHub Brief provides a clear overview of how the agency’s facility inspections are structured under its revised framework.

## Key Topics

- [Compliance](https://qualityhub.com/tag/compliance/)
- [FDA](https://qualityhub.com/tag/fda/)
- [MedTech](https://qualityhub.com/tag/medtech/)
- [News & Analysis](https://qualityhub.com/category/news-analysis/)
- [Regulation](https://qualityhub.com/tag/regulation/)


# Last updated: 2026-08-12T21:18:56+00:00