FDA QMSR Transition & Inspection Readiness Services

Any organization that manufactures, prepares, propagates, compounds, assembles, or processes medical devices for the U.S. market should be planning for FDA's Quality Management System Regulation (QMSR), which becomes effective on February 2, 2026.^[2] QMSR updates FDA's device quality requirements and aligns the regulation with ISO 13485:2016 (incorporated by reference) while keeping certain FDA-specific expectations.^[2]

This directory is most relevant if you are:

• A medical device or IVD manufacturer (including SaMD/connected devices) transitioning from a "21 CFR Part 820 mindset" to an ISO 13485-aligned system that still satisfies FDA expectations.^[2]
• A contract manufacturer or critical supplier who will be audited for QMSR alignment by customers and/or inspected by FDA, depending on your role in device production.^[2]
• A startup preparing a first U.S. submission (510(k), De Novo, PMA) that needs a right-sized, inspection-ready quality system—not just templates.
• A company with prior findings (e.g., repeat observations, CAPA issues, design control gaps) that needs remediation and a credible sustainment plan.

Important nuance: QMSR aligns to ISO 13485, but ISO 13485 certification is not required to comply with QMSR—FDA makes that explicit.^[2] Many teams still pursue certification for business reasons (customer requirements, global market access), but compliance and certification are not the same thing.

Most QMSR transition projects combine regulatory interpretation + practical quality engineering. Providers typically offer a mix of the following (often as modular workstreams):

• QMSR/ISO 13485 gap assessment (documentation + records + interviews) with a prioritized remediation plan and clear evidence expectations.
• Part 820 → QMSR mapping to identify what stays, what changes, and where FDA-specific expectations still apply under the QMSR framework.^[2]
• SOP & template remediation: CAPA, complaint handling, risk management interfaces, supplier controls, training/competence, change control, and document/record control.
• Design & development support: design control modernization, DHF structure, traceability improvements, and design change governance.
• Internal audit program upgrade and mock inspections (inspection simulations, interview coaching, evidence-room readiness).
• Management review strengthening: actionable inputs/outputs, measurable objectives, escalation rules, and executive accountability.
• Training & role-based enablement: "what changed in QMSR," evidence expectations, and how to sustain compliance across teams.

Inspection-readiness specifics: Under QMSR, FDA states it will have authority to inspect records required by ISO 13485, including internal audit and management review records.^[2] Many inspection readiness engagements therefore focus on (1) record integrity, (2) objective evidence linking procedures to practice, and (3) fast retrieval under inspection conditions.

Pricing for QMSR transition and inspection readiness varies widely because the "product" is really a combination of scope, urgency, and risk. In quotes, expect providers to ask about:

• Number of sites and functions (design only vs. manufacturing vs. both; multiple locations increases coordination and evidence).
• Device/IVD portfolio complexity (sterile, implantable, software-enabled, combination product interfaces, etc.).
• Current maturity: do you already have a functioning QMS, or are you building from scratch?
• ISO 13485 alignment status: existing ISO 13485 certification (or near-ready) can reduce baseline remediation, but still requires verifying QMSR expectations are met.^[2]
• Urgency: "start in 72 hours" projects cost more because they require rapid staffing, focused sprints, and tighter executive availability.
• Deliverables: a gap report alone vs. hands-on SOP rewrites, training delivery, internal audits, and mock inspection execution.

Common pricing models: fixed-scope packages (gap assessment), weekly/monthly retainers (remediation), or hybrid models (fixed assessment + retainer for execution). If you're comparing quotes, ask providers to separate (1) assessment, (2) remediation, and (3) inspection-readiness activities so you can compare apples-to-apples.

Tip: For time-critical work, prioritize providers that can commit to a written sprint plan, clear acceptance criteria, and named resources—rather than vague "advisory" language.

Because QMSR is both regulatory and operational, the best provider for you is the one that can produce inspection-ready evidence, not just documents. Use this checklist when comparing providers:

• FDA inspection experience: Have they supported inspections, mock inspections, or remediation after observations?
• ISO 13485 implementation depth: Can they translate clauses into practical workflows, records, and training?
• Deliverable clarity: Will you get a prioritized gap matrix, updated SOP set, training records, and audit-ready evidence?
• Speed + realism: Can they start quickly without promising impossible timelines?
• Change control discipline: Do they help you implement and sustain, not just "rewrite everything"?
• Team fit: Do they have the right mix—quality engineers, auditors, and regulatory/inspection specialists?

Questions to ask in the first call:

1. What are the top 10 gaps you see when companies move from Part 820 to an ISO 13485-aligned system?
2. How do you ensure procedures match real practice (objective evidence), not just templates?
3. What records will we need to have inspection-ready under QMSR (and how do you test retrieval)?^[2]
4. What does your "mock inspection" look like (agenda, sampling, interviews, closeout)?
5. How do you handle supplier controls and outsourced processes?

Red flags: (1) "We'll certify you for QMSR" (certification is not required and is different from compliance), (2) refusing to define deliverables, (3) generic templates with no evidence plan, and (4) no plan for training + sustainment.

A realistic QMSR transition is a phased program. Even if you are moving fast, aim for a sequence that produces usable outputs every 1–2 weeks:

1. Week 0–1 (Intake & scoping): portfolio + sites + risk profile, current QMS artifacts, top pain points, prior findings.
2. Week 1–2 (Gap assessment & prioritization): QMSR/ISO gap matrix, evidence needs, "top 5" remediation sprints.
3. Weeks 2–6 (Remediation sprints): SOP + record updates, training, implementation support, and quick-win controls (document/record control, change control).
4. Weeks 4–8 (Internal audit + readiness): audit program updates, targeted audits on high-risk processes, CAPA program tightening.
5. Weeks 6–10 (Mock inspection): sampling, interviews, evidence-room drills, closeout with prioritized corrective actions.
6. Ongoing (Sustainment): management review cadence, metrics, supplier monitoring, and periodic internal audits.

Fast-track option: Some providers offer a "start in 72 hours" kickoff for urgent timelines, focusing on top-risk processes first, then expanding scope.

• Device/IVD portfolio list + intended use summary
• Site list (design/manufacturing/testing) + outsourced processes
• High-level QMS document list (SOP index) + last revision dates
• Last internal audit summary + open CAPAs (if any)
• Management review minutes/outputs (if available)
• Complaint/NC trends (top 3–5 issues)
• Supplier list (critical suppliers) + qualification approach
• Any prior FDA inspection outcomes and follow-ups (if applicable)

Why this matters: FDA notes that under QMSR it has authority to inspect ISO 13485-required records (including internal audits and management reviews).^[2] Being organized before you start makes provider quotes more accurate and timelines more realistic.