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Insurance Buying Guide for Medical Device Businesses
Which Insurance Should You Consider?
Consider product liability, product recall, cyber liability, commercial property, and tools, equipment and inland marine. Start with the coverages tied to your day-to-day operations, then use the situations and buying questions below to compare your options.
Product liability
You move from prototype work into a device study, contract manufacturing, distribution, or commercial sale.
Ask a specialist how the proposed product-liability wording treats your device, intended use, software, study stage, and sales territories.[1][2]
Ask Before Buying
Which devices, accessories, stages, territories, and allegations are included, and what exclusions, limits, and sublimits apply?
Product recall
A defect, field issue, customer request, or product change could lead you to stop sales or withdraw a device.
Ask a specialist whether a separate product-recall form is available for your device and what event and expense definitions it uses.[1]
Ask Before Buying
Which events trigger the form, and are customer notification, shipping, replacement, consultant, and lost-income costs included or excluded?
Cyber liability
Your device connects to a network, transmits patient data, or depends on a cloud or software vendor.
NAIC says cyber policies are customized and distinguishes first-party incident costs from third-party claims. Describe the connected features and vendors, then compare the actual cyber terms with those systems.[3][4]
Ask Before Buying
How do the proposed terms treat device data, vendors, incident response, service interruption, and claims alleging a connected feature caused harm?
Commercial property
You lease a workshop or lab, buy production equipment, or keep prototypes and inventory at a site.
California’s commercial guide describes property at a business location and explains that values, covered causes, and deductibles affect the quote. List each site, machine, prototype, and inventory value.[5]
Ask Before Buying
Which property and locations are scheduled, what valuation basis applies, and which causes of loss, deductibles, and exclusions affect the quote?
Tools, equipment and inland marine
You take prototypes, demo devices, tools, or test equipment to a customer, trade show, or study site.
Ask whether inland-marine terms fit the equipment and movement you need to insure. California’s guide treats movable and in-transit property separately from property at a fixed location; check the actual items, routes, and stages.[5]
Ask Before Buying
Which devices, tools, routes, handlers, and loading or installation stages are addressed, and what exclusions apply while equipment is away from the listed site?
Before Your First Commercial Sale
List every device and accessory, intended use, sales territory, and manufacturing or service role. FDA says the Quality Management System Regulation applies to finished device manufacturers intending commercial distribution; use that distinction to describe your current stage, not to infer insurance coverage.[1]
If a test or diagnostic feature is part of the product, describe the assay, instrument, specimen workflow, and result use separately. FDA’s IVD overview says classification affects the product pathway and is nonbinding guidance.[2]
Before You Sign a Manufacturing Contract
Identify which entity designs, makes, labels, tests, installs, and services each device. Share customer indemnities and manufacturer or distributor agreements with the broker, then ask where those activities appear in the application and which exclusions or sublimits affect them.[1][5]
For connected products, list software features, data flows, and vendors. Compare cyber and product-related questions with the actual wording rather than assuming a connected-device feature is handled by one policy label.[3][4]
Providers to Compare by Coverage
Product liability
Alliance Risk
Spot Score
Review Score
Not enough ratings
Amelia Risk
Spot Score
Review Score
2.0/ 10
Product recall
Alliance Risk
Spot Score
Review Score
Not enough ratings
Amelia Risk
Spot Score
Review Score
2.0/ 10Cyber liability
Alliance Risk
Spot Score
Review Score
Not enough ratings
Amelia Risk
Spot Score
Review Score
2.0/ 10
Commercial property
Alliance Risk
Spot Score
Review Score
Not enough ratings
CFC
Spot Score
Review Score
Not enough ratings
Tools, equipment and inland marine
Alliance Risk
Spot Score
Review Score
Not enough ratings
Common Questions
Does FDA device status tell me what my insurance covers?
No. FDA guidance helps describe the device, intended use, and product stage. Ask the broker to identify the forms and exclusions relevant to a claim, recall expense, or customer contract requirement.[1][2]
Read the Full AnswerWhat should I disclose before the first device shipment?
Before the first shipment, give the broker the device’s intended use, manufacturer and distributor roles, territory, and destination; add contract, installation, service, and transit details when they apply.[1][5]
Read the Full AnswerSources and Further Reading
- Quality Management System Regulation (QMSR) — U.S. Food and Drug Administration. Effective-date statement; Applicability of the QMSR; CGMP Exemptions
Confirm the stated finished-device manufacturer scope when describing your product stage; it does not determine insurance response.
- Overview of IVD Regulation — U.S. Food and Drug Administration. IVD definition and classification sections; FDA notes the overview is nonbinding
Describe an in-vitro diagnostic product and its intended use when it is part of your device.
- Cybersecurity — National Association of Insurance Commissioners, Center for Insurance Policy and Research. Cyber risk categories and customized-policy qualification
- Cyber Insurance: Cybersecurity for Small Business — National Association of Insurance Commissioners. First-party and third-party coverage sections; vendor-held data and defense wording prompts
- Commercial Insurance Guide — California Department of Insurance. Commercial property; inland marine; boiler and machinery; commercial general liability
Review California guidance on business property, liability, and movable property; compare it with the policy form.
- Small Business Insurance — National Association of Insurance Commissioners. General liability, products, and other business liability sections
Spot, a product of Tools for Enlightenment, publishes this guide and works in the commercial insurance market. This is general buyer education; policy terms and state-specific obligations determine coverage and requirements.
Updated 2026-09-28. Editorial Policy
Get Help With Insurance Buying and Renewals.
Get help buying coverage and managing renewals, with less paperwork for your team. Start with a free consultation.