The Qualio Blog
Insights on product development, quality management, and regulatory compliance for teams building life-saving products.
21 CFR Part 11 did not change in 2026. Everything around it did.
Part 11 has been stable since 1997. The number of systems it applies to has not. QMSR took effect in February 2026, and the FDA's updated Computer Software Assurance guidance pulled cloud and SaaS tools formally into scope. Here is how to run the checklist so the answers stay true.
Your quality team has become an integration layer
Design inputs live in Jira. Test results live in TestRail. Complaints live in Zendesk. The reconciliation work in between is where quality capacity goes, and the FDA's 2026 guidance has already brought those systems inside your compliance perimeter.
Every quality management system on your shortlist will pass your evaluation
Most quality management software evaluations cannot separate the field, because they measure what every vendor already does. Three questions that sort it.
The compliance tax you are already paying
Compliance cost is real and rarely measured. Put a number on what you spend today across audit prep, QA capacity, documents, and consultants.
The Sidekick Becomes a Coworker: What a Quality Leader Learned About Trusting AI With Compliance
One quality leader explains why AI needs to become a coworker, not just a sidekick, before audit prep stops being a last-minute scramble.
The EU Expands Its "Well-Established Technologies" List Again
The EU expanded its MDR "well-established technologies" list again, growing it roughly fivefold. See which device categories now qualify for reduced requirements.
MHRA's 2026 Devices Reform: What Changes and When
MHRA's draft Medical Devices (Amendment) Regulations 2026 reshape GB's pre-market framework, adoption expected December 2026. See what changes and when.
FDA's Risk-Based Inspection Shift: What It Actually Rewards
FDA's revised PAI guide takes effect August 2026, favoring risk-based reviews over onsite inspections by default. See what the shift actually rewards.
ISO 14971 in the Age of AI: What ISO/TS 24971-2:2026 Adds
ISO/TS 24971-2:2026 guides ML risk management under ISO 14971. See what the new companion standard covers, and what it means for your risk file.
What the FDA's AI Device Software Guidance Signals for Your Traceability
FDA's draft AI-enabled device guidance demands dataset provenance and post-market monitoring across the TPLC. See what it means for your traceability now.