Analysis for people who have to defend the answer.
Regulatory and quality analysis on QMSR, risk management, inspection readiness, remediation, integration and the responsible use of AI in regulated environments. Written for quality and regulatory leaders, not for search engines.
ISO 13485 Clause 7.1 is now FDA’s most-cited finding. Here is what a compliant risk-planning process actually contains.
Clause 7.1 requires risk-based planning across product realization — not a design-stage hazard analysis. Most procedures do not survive that reading.
Your management review minutes are now FDA evidence.
The provision that shielded management review records, internal audit reports and supplier audit reports from routine FDA review no longer applies. Most organizations have never written them expecting an outside reader.
Inspections after QSIT: a practical read of Compliance Program 7382.850.
Six QMS Areas, four other applicable requirements, no statistical sampling and mid-inspection escalation. Your inspection SOP was written for a program FDA retired.
What we are writing next
Published as they are finished, and only when we have something specific to say.
- Quality Systems — QMSR legacy records: writing the comparative analysis FDA expects
- FDA & Regulatory Updates — EUDAMED and the November 2026 legacy-device registration deadline
- FDA & Regulatory Updates — Don’t plan on MDR 2.0: building a transition plan that works either way
- FDA & Regulatory Updates — Notified body capacity, honestly: reading the primary data
- Digital Transformation — CSA is final — and it raised the bar on suppliers, not lowered it
- AI & Compliance — What the EU AI Act timeline change does and does not buy a manufacturer
- AI & Compliance — PCCP as a quality-system capability, not a submission exhibit
- Integration — Post-merger QMS integration under the QMSR
- Risk Management — Consolidating a large FMEA estate into a governed risk file structure
- CAPA & Remediation — CAPA effectiveness verification that would actually detect recurrence
- Quality Systems — Supplier risk when the audit evidence is an email thread
- AI & Compliance — Where AI belongs in a quality system — and five places it does not yet
- AI & Compliance — Validating the AI you already installed
- Pharmaceutical Quality — Sterility assurance and parametric release: removing hold time defensibly
- Quality Systems — Building a quality function from zero: the first 90 days
- Quality Systems — Staff augmentation or managed service? Choosing the engagement model
- Medical Device Quality — Design controls that survive an agile release cadence
Let’s solve the quality or compliance challenge standing in your way.
Tell us what you are dealing with. We will tell you honestly whether it is something ClariSure should take on, and what the path forward looks like.