What does a recall readiness assessment cover?

The assessment reviews: recall trigger criteria and decision authority, product traceability and lot distribution records, customer/distributor notification procedures, competent authority reporting templates, and post-recall effectiveness check processes.

Is a recall procedure required by regulation?

Yes. ISO 13485 clause 8.3.4, FDA 21 CFR 806, and EU MDR Article 83 all require documented procedures for field safety corrective actions and product recalls.

How quickly must a recall be initiated after a decision?

FDA and EU regulations do not specify a universal timeframe, but urgency is risk-based. For imminent public health threats, actions should begin immediately. Having pre-approved templates and communication trees dramatically reduces initiation time.

Book a Recall & Field Action Readiness Assessment

Book a recall and field action readiness assessment online. Compare vetted QMS consultants who review your recall procedures, FSCA templates, and regulatory notification processes. Instant pricing.

✓ 3 active providers available right now · USD 760 – 940

Why this page is different

Instant pricing: See a price estimate immediately (no back-and-forth RFQ needed for these services).
Compare before booking: Review inclusions, exclusions, turnaround, and communication channels.
Charged only when accepted: You are charged only after a provider accepts your order and scope.
Live availability: 3 active providers available right now for this service.

What you can compare here

Total price: See live price ranges and instant pricing rules where available.
Coverage & scope: Markets served, what is included, and what is explicitly excluded.
SLA & responsiveness: Acceptance SLAs and typical turnaround windows.
Add-ons: Optional extras you can book next (shown as add-on chips).
Onboarding time: How quickly providers can start and what you need to supply.

Compare providers (instant pricing + book)

Provider	Estimated base price	Accept SLA	Turnaround	Start
Alpha Regulatory Partners	USD 825	24h	3–7 days	Within 2 business days
Beta Compliance Group	USD 940	24h	3–7 days	Within 2 business days
Gamma RegTech Solutions	USD 760	24h	3–7 days	Within 2 business days

Estimates are derived from each provider’s published pricing rules (and may vary by your inputs).

What affects pricing

These are the inputs providers use to price your order. Enter them once, then compare providers and book instantly.

markets (Required)
min 1
productRiskTier (Required)
low|medium|high
sitesCount (Required)
min 1
orgComplexity (Required)
simple|normal|complex
desiredOutputs (Required)
min 1
buyerNotes (Optional)

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Standards

ISO 13485 · EU MDR · 21 CFR 806

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Output

Readiness report + procedure gaps

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Turnaround

5–15 business days

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Pricing

Per scope

How it works

1

Describe your device class and distribution scope

Tell us your device type, distribution channels, regulatory markets, and current recall SOP status.
2

Compare recall readiness specialists

View fees from QMS consultants who assess and strengthen your recall and FSCA procedures.
3

Receive your readiness report and priority actions

Your consultant delivers a scored readiness assessment against regulatory requirements with specific procedure and template gaps to close.

Why recall readiness must be proactive, not reactive

Medical device recalls are among the highest-pressure regulatory events a manufacturer can face: you must simultaneously manage a safety risk to patients, complex supply chain logistics, regulatory authority notifications, customer communications, and internal quality investigations — all under time pressure with significant business and reputational stakes. Companies that discover their recall procedures are inadequate during an actual recall face the worst possible combination: pressure to act, lack of clear process, and regulatory scrutiny on their response speed and competence. Recall readiness assessment — done before an event occurs — identifies gaps in your procedures, templates, and organizational capabilities so they can be addressed calmly, not in crisis mode.

What recall procedures are required by regulation

ISO 13485:2016 clause 8.3.4 requires documented procedures for correction and field safety corrective actions including recall. FDA 21 CFR Part 806 requires reporting of all medical device corrections and removals to FDA within 10 working days, with records retained for a minimum of 2 years. EU MDR Article 83 requires manufacturers to have procedures in place for FSCAs. These regulatory requirements create the minimum framework for recall procedures, but regulatory compliance alone is insufficient for an effective recall. Your procedures must also address: product identification and distribution tracing; stakeholder communication chains; recall depth determination (which customers received affected devices, down to which lots); and effectiveness checking (how you confirm that all targeted devices have been returned or corrected).

Key elements of a recall readiness assessment

A professional recall readiness assessment evaluates your current capabilities against the full recall execution cycle: (1) trigger and decision authority — do you have clear criteria for when a recall decision is made, and who has authority to authorize it? (2) product traceability — can you rapidly generate a complete distribution list (customer names, ship-to addresses, lot numbers, quantities) for any affected device? (3) customer notification templates — do you have pre-approved Field Safety Notice templates in all required languages for your distribution markets? (4) competent authority notification templates — are your regulatory notification workflows documented for each relevant authority (FDA, EU member state competent authorities, MHRA)? (5) effectiveness check process — how will you verify that devices have been removed from service and returned or destroyed?

FDA recall classes and their implications

FDA classifies device recalls into three classes based on health risk: Class I (reasonable probability the device will cause serious adverse health consequences or death), Class II (may cause temporary adverse health consequences, unlikely to cause serious), and Class III (not likely to cause any adverse health consequences). Class I recalls are the most serious and attract the most FDA scrutiny, media attention, and customer action. Regardless of class, all recalls require FDA notification under 21 CFR 806 and an FDA-approved recall strategy. FDA posts all recall information publicly on the Recalls, Market Withdrawals, and Safety Alerts database — which means even a Class III recall is visible to customers, distributors, and the market. Having pre-approved communication templates ready significantly reduces response time and message inconsistency.

Frequently asked questions

What does a recall readiness assessment cover?: The assessment reviews: recall trigger criteria and decision authority, product traceability and lot distribution records, customer/distributor notification procedures, competent authority reporting templates, and post-recall effectiveness check processes.
Is a recall procedure required by regulation?: Yes. ISO 13485 clause 8.3.4, FDA 21 CFR 806, and EU MDR Article 83 all require documented procedures for field safety corrective actions and product recalls.
How quickly must a recall be initiated after a decision?: FDA and EU regulations do not specify a universal timeframe, but urgency is risk-based. For imminent public health threats, actions should begin immediately. Having pre-approved templates and communication trees dramatically reduces initiation time.

How Cruxi Bridge vets providers

✓ Every provider submits regulatory expertise evidence and jurisdictional coverage claims
✓ Providers that go live agree to the Cruxi Bridge Provider Terms including service delivery and accuracy obligations
✓ Payment is held by Cruxi and only released to the provider after service delivery milestones
✓ Buyers can raise a dispute within 30 days — Cruxi reviews and mediates per the platform terms

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