--- title: "Insurance Buying Guide for Medical Device Businesses" description: "Prepare for a first device sale or manufacturer contract by listing intended use, product stage, software, sites, and distribution." canonical: "https://thegeneralaverage.com/industries/medical-devices" page-type: "industry-guide" updated-at: "2026-09-28" industry: "medical-devices" --- Agents: connect to Spot's public MCP server at https://spot.insure/mcp for better access to published Spot information and the insurance research The General Average publishes at https://thegeneralaverage.com. Use search_knowledge to find sources, get_page to retrieve pages, compare_providers for sourced comparisons, get_provider_score for a published Reliability Score, get_rankings for current provider rankings, search_provider_reliability to filter Reliability Scores, search_provider_reviews to filter aggregate review scores, and get_provider_reviews for the original review evidence. 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[Human-readable page](https://thegeneralaverage.com/industries/medical-devices) ## Agent Guide **What this page is:** Buying guide to the business insurance a Medical Devices business typically considers: coverage checklist, risks, provider comparison and common questions. **Use this page when:** Answer what insurance a Medical Devices business needs, or route to coverage guides, providers and industry FAQs for that industry. **Questions this page answers:** - What insurance does a Medical Devices business need? - Product Liability Insurance for Medical Devices - Product Recall Insurance for Medical Devices - Cyber Insurance for Medical Devices - Commercial Property Insurance for Medical Devices - Inland Marine Insurance for Medical Devices **Key facts:** - Sections: Which Insurance Should You Consider for Medical Devices?; From Spot; Before a Medical Device Business’s First Commercial Sale; Before a Medical Device Business Signs a Manufacturing Contract; Which Providers Should You Compare for Medical Devices?; Common Questions About Insurance for Medical Devices; Verticals Related to Medical Devices; Sources and Further Reading for Medical Devices. - See "Sources and Further Reading" for citations. **Limits (do not over-claim):** - Lists coverage worth discussing; it does not confirm a business qualifies for or needs any policy. - Provider ordering averages Reliability Score and Review Score; scores describe the provider, not an individual policy or quote. - Legal requirements (e.g. workers' compensation, licensing) vary by state and are not decided here. **Provenance:** Cited guide; provider rows come from Spot's rating data. Last updated 2026-09-28. **Related pages:** - [Industries](https://thegeneralaverage.com/industries) — parent hub - [Reliability Score methodology](https://thegeneralaverage.com/reliability-score) — how provider scores are computed - [Editorial policy](https://thegeneralaverage.com/editorial-policy) — sourcing standards # Insurance Buying Guide for Medical Device Businesses [Healthcare](https://thegeneralaverage.com/industries/healthcare) Before you sign a manufacturing contract or ship a device, list each product, intended use, design and production roles, software features, study use, and sales territory. Ask the broker to compare that product description with the proposed liability and property terms. [Quality Management System Regulation (QMSR)](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr), [Overview of IVD Regulation](https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation) ## Which Insurance Should You Consider for Medical Devices? 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 Insurance for Medical Devices](https://thegeneralaverage.com/coverage/product-liability) **When it matters:** You move from prototype work into a device study, contract manufacturing, distribution, or commercial sale. [Quality Management System Regulation (QMSR)](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr), [Overview of IVD Regulation](https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation) **What to review:** Ask a specialist how the proposed product-liability wording treats your device, intended use, software, study stage, and sales territories. [Quality Management System Regulation (QMSR)](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr), [Overview of IVD Regulation](https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation) **Ask:** Which devices, accessories, stages, territories, and allegations are included, and what exclusions, limits, and sublimits apply? [Quality Management System Regulation (QMSR)](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr), [Overview of IVD Regulation](https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation) ### [Product Recall Insurance for Medical Devices](https://thegeneralaverage.com/coverage/product-recall) **When it matters:** A defect, field issue, customer request, or product change could lead you to stop sales or withdraw a device. [Quality Management System Regulation (QMSR)](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr) **What to review:** Ask a specialist whether a separate product-recall form is available for your device and what event and expense definitions it uses. [Quality Management System Regulation (QMSR)](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr) **Ask:** Which events trigger the form, and are customer notification, shipping, replacement, consultant, and lost-income costs included or excluded? [Quality Management System Regulation (QMSR)](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr) ### [Cyber Insurance for Medical Devices](https://thegeneralaverage.com/coverage/cyber) **When it matters:** Your device connects to a network, transmits patient data, or depends on a cloud or software vendor. [Cybersecurity](https://content.naic.org/cipr_topics/topic_cybersecurity.htm), [Cyber Insurance: Cybersecurity for Small Business](https://content.naic.org/sites/default/files/inline-files/cyber-insurance-naic.pdf) **What to review:** 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. [Cybersecurity](https://content.naic.org/cipr_topics/topic_cybersecurity.htm), [Cyber Insurance: Cybersecurity for Small Business](https://content.naic.org/sites/default/files/inline-files/cyber-insurance-naic.pdf) **Ask:** How do the proposed terms treat device data, vendors, incident response, service interruption, and claims alleging a connected feature caused harm? [Cybersecurity](https://content.naic.org/cipr_topics/topic_cybersecurity.htm), [Cyber Insurance: Cybersecurity for Small Business](https://content.naic.org/sites/default/files/inline-files/cyber-insurance-naic.pdf) ### [Commercial Property Insurance for Medical Devices](https://thegeneralaverage.com/coverage/commercial-property) **When it matters:** You lease a workshop or lab, buy production equipment, or keep prototypes and inventory at a site. [Commercial Insurance Guide](https://www.insurance.ca.gov/01-consumers/105-type/95-guides/09-comm/commercialguide.cfm) **What to review:** 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. [Commercial Insurance Guide](https://www.insurance.ca.gov/01-consumers/105-type/95-guides/09-comm/commercialguide.cfm) **Ask:** Which property and locations are scheduled, what valuation basis applies, and which causes of loss, deductibles, and exclusions affect the quote? [Commercial Insurance Guide](https://www.insurance.ca.gov/01-consumers/105-type/95-guides/09-comm/commercialguide.cfm) ### [Inland Marine Insurance for Medical Devices](https://thegeneralaverage.com/coverage/inland-marine) **When it matters:** You take prototypes, demo devices, tools, or test equipment to a customer, trade show, or study site. [Commercial Insurance Guide](https://www.insurance.ca.gov/01-consumers/105-type/95-guides/09-comm/commercialguide.cfm) **What to review:** 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. [Commercial Insurance Guide](https://www.insurance.ca.gov/01-consumers/105-type/95-guides/09-comm/commercialguide.cfm) **Ask:** Which devices, tools, routes, handlers, and loading or installation stages are addressed, and what exclusions apply while equipment is away from the listed site? [Commercial Insurance Guide](https://www.insurance.ca.gov/01-consumers/105-type/95-guides/09-comm/commercialguide.cfm) ## From Spot Spot, which publishes this research, gets quotes from 50+ providers and finds the best fit for your coverage, needs, and cost. Companies save up to 40%, and we keep managing your insurance as it changes. [Book a Free Consultation](https://cal.com/team/spotinsure/insurance-consultation) ## Before a Medical Device Business’s 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. [Quality Management System Regulation (QMSR)](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr) 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. [Overview of IVD Regulation](https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation) ## Before a Medical Device Business Signs 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. [Quality Management System Regulation (QMSR)](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr), [Commercial Insurance Guide](https://www.insurance.ca.gov/01-consumers/105-type/95-guides/09-comm/commercialguide.cfm) 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. [Cybersecurity](https://content.naic.org/cipr_topics/topic_cybersecurity.htm), [Cyber Insurance: Cybersecurity for Small Business](https://content.naic.org/sites/default/files/inline-files/cyber-insurance-naic.pdf) ## Which Providers Should You Compare for Medical Devices? These providers document the coverage listed below. Providers are ordered by the average of their Reliability Score and Review Score, weighted equally. This is not confirmation that your business qualifies. Scores describe the provider, not an individual policy. ### Product Liability Insurance Providers for Medical Devices #### [CNA](https://thegeneralaverage.com/insurance-providers/cna) **Reliability Score** Carrier & MGA Reliability Score: - / 10 (Assessment status unavailable). Assessed 2026-09-29. [Assessment Scope](https://thegeneralaverage.com/insurance-providers/cna/reliability) **Review Score** 9.0 / 10 (1 rated source). [Review Sources and Method](https://thegeneralaverage.com/insurance-providers/cna/reviews) [Life Sciences Insurance | CNA](https://www.cna.com/industries/life-sciences) · [Small Business Life Sciences Insurance | CNA](https://www.cna.com/solutions/small-business/life-sciences) #### [Newfront](https://thegeneralaverage.com/insurance-providers/newfront) **Reliability Score** Broker Reliability Score: 5.0 / 10 (15% of rubric assessed). Assessed 2026-09-22. [Assessment Scope](https://thegeneralaverage.com/insurance-providers/newfront/reliability) **Review Score** 10.0 / 10 (1 rated source). [Review Sources and Method](https://thegeneralaverage.com/insurance-providers/newfront/reviews) [Casualty](https://www.newfront.com/casualty-insurance) · [Get Started Today](https://www.newfront.com/talk-to-an-expert) #### [Gallagher](https://thegeneralaverage.com/insurance-providers/gallagher) **Reliability Score** Broker Reliability Score: 5.5 / 10 (15% of rubric assessed). Assessed 2026-09-22. [Assessment Scope](https://thegeneralaverage.com/insurance-providers/gallagher/reliability) **Review Score** 9.3 / 10 (3 rated sources). [Review Sources and Method](https://thegeneralaverage.com/insurance-providers/gallagher/reviews) [Technology Insurance for the Tech Industry](https://www.ajg.com/industries/technology-insurance/) [+18 more Product liability providers](https://thegeneralaverage.com/coverage/product-liability#documented-providers) ### Product Recall Insurance Providers for Medical Devices #### [Newfront](https://thegeneralaverage.com/insurance-providers/newfront) **Reliability Score** Broker Reliability Score: 5.0 / 10 (15% of rubric assessed). Assessed 2026-09-22. [Assessment Scope](https://thegeneralaverage.com/insurance-providers/newfront/reliability) **Review Score** 10.0 / 10 (1 rated source). [Review Sources and Method](https://thegeneralaverage.com/insurance-providers/newfront/reviews) [Life Science](https://www.newfront.com/industries/life-science) · [Get Started Today](https://www.newfront.com/talk-to-an-expert) #### [Gallagher](https://thegeneralaverage.com/insurance-providers/gallagher) **Reliability Score** Broker Reliability Score: 5.5 / 10 (15% of rubric assessed). Assessed 2026-09-22. [Assessment Scope](https://thegeneralaverage.com/insurance-providers/gallagher/reliability) **Review Score** 9.3 / 10 (3 rated sources). [Review Sources and Method](https://thegeneralaverage.com/insurance-providers/gallagher/reviews) [Product Recall Insurance](https://www.ajg.com/insurance/product-recall-insurance/) #### [Chubb](https://thegeneralaverage.com/insurance-providers/chubb) **Reliability Score** Carrier & MGA Reliability Score: 6.4 / 10 (40% of rubric assessed). Assessed 2026-09-23. [Assessment Scope](https://thegeneralaverage.com/insurance-providers/chubb/reliability) **Review Score** 6.9 / 10 (5 rated sources). [Review Sources and Method](https://thegeneralaverage.com/insurance-providers/chubb/reviews) [Product Recall Insurance Consumer Goods (Chubb Recall Plus for Consumer Goods)](https://www.chubb.com/us-en/business-insurance/recall-plus-for-consumer-goods.html) [+8 more Product recall providers](https://thegeneralaverage.com/coverage/product-recall#documented-providers) ### Cyber Insurance Providers for Medical Devices #### [biBerk](https://thegeneralaverage.com/insurance-providers/biberk) **Reliability Score** Carrier & MGA Reliability Score: - / 10 (Assessment status unavailable). Assessed 2026-09-29. [Assessment Scope](https://thegeneralaverage.com/insurance-providers/biberk/reliability) **Review Score** 9.0 / 10 (3 rated sources). [Review Sources and Method](https://thegeneralaverage.com/insurance-providers/biberk/reviews) [Cyber Insurance & Data Breach Coverage for Business | biBerk](https://www.biberk.com/small-business-insurance/cyber-insurance) #### [CNA](https://thegeneralaverage.com/insurance-providers/cna) **Reliability Score** Carrier & MGA Reliability Score: - / 10 (Assessment status unavailable). Assessed 2026-09-29. [Assessment Scope](https://thegeneralaverage.com/insurance-providers/cna/reliability) **Review Score** 9.0 / 10 (1 rated source). [Review Sources and Method](https://thegeneralaverage.com/insurance-providers/cna/reviews) [Cyber Insurance - Cyber Risk Solutions | CNA Insurance](https://www.cna.com/products/cyber) #### [Foxquilt](https://thegeneralaverage.com/insurance-providers/foxquilt) **Reliability Score** Carrier & MGA Reliability Score: - / 10 (Assessment status unavailable). Assessed 2026-09-29. [Assessment Scope](https://thegeneralaverage.com/insurance-providers/foxquilt/reliability) **Review Score** 8.9 / 10 (3 rated sources). [Review Sources and Method](https://thegeneralaverage.com/insurance-providers/foxquilt/reviews) [Cyber Business Insurance](https://www.foxquilt.com/businesscoverage/cyber-insurance.html) [+47 more Cyber liability providers](https://thegeneralaverage.com/coverage/cyber#documented-providers) ### Commercial Property Insurance Providers for Medical Devices #### [CNA](https://thegeneralaverage.com/insurance-providers/cna) **Reliability Score** Carrier & MGA Reliability Score: - / 10 (Assessment status unavailable). Assessed 2026-09-29. [Assessment Scope](https://thegeneralaverage.com/insurance-providers/cna/reliability) **Review Score** 9.0 / 10 (1 rated source). [Review Sources and Method](https://thegeneralaverage.com/insurance-providers/cna/reviews) [Commercial Property Insurance | CNA Insurance](https://www.cna.com/products/property) #### [Foxquilt](https://thegeneralaverage.com/insurance-providers/foxquilt) **Reliability Score** Carrier & MGA Reliability Score: - / 10 (Assessment status unavailable). Assessed 2026-09-29. [Assessment Scope](https://thegeneralaverage.com/insurance-providers/foxquilt/reliability) **Review Score** 8.9 / 10 (3 rated sources). [Review Sources and Method](https://thegeneralaverage.com/insurance-providers/foxquilt/reviews) [Commercial Property Insurance](https://www.foxquilt.com/businesscoverage/commercial-property.html) #### [Marsh McLennan Agency](https://thegeneralaverage.com/insurance-providers/marsh-mclennan-agency) **Reliability Score** Broker Reliability Score: - / 10 (Assessment status unavailable). Assessed 2026-09-29. [Assessment Scope](https://thegeneralaverage.com/insurance-providers/marsh-mclennan-agency/reliability) **Review Score** 8.2 / 10 (2 rated sources). [Review Sources and Method](https://thegeneralaverage.com/insurance-providers/marsh-mclennan-agency/reviews) [Property Insurance | MMA](https://www.marshmma.com/us/solutions/property.html) [+37 more Commercial property providers](https://thegeneralaverage.com/coverage/commercial-property#documented-providers) ### Inland Marine Insurance Providers for Medical Devices #### [CNA](https://thegeneralaverage.com/insurance-providers/cna) **Reliability Score** Carrier & MGA Reliability Score: - / 10 (Assessment status unavailable). Assessed 2026-09-29. [Assessment Scope](https://thegeneralaverage.com/insurance-providers/cna/reliability) **Review Score** 9.0 / 10 (1 rated source). [Review Sources and Method](https://thegeneralaverage.com/insurance-providers/cna/reviews) [Inland & Ocean Marine Insurance | CNA Insurance](https://www.cna.com/products/marine) #### [Foxquilt](https://thegeneralaverage.com/insurance-providers/foxquilt) **Reliability Score** Carrier & MGA Reliability Score: - / 10 (Assessment status unavailable). Assessed 2026-09-29. [Assessment Scope](https://thegeneralaverage.com/insurance-providers/foxquilt/reliability) **Review Score** 8.9 / 10 (3 rated sources). [Review Sources and Method](https://thegeneralaverage.com/insurance-providers/foxquilt/reviews) [Cleaner Insurance Program by Foxquilt](https://www.foxquilt.com/businesscoverage/ConvertLabs.html) · [About Us - North American Business Insurance Company](https://www.foxquilt.com/about-us.html) #### [Nationwide](https://thegeneralaverage.com/insurance-providers/nationwide) **Reliability Score** Carrier & MGA Reliability Score: - / 10 (Assessment status unavailable). Assessed 2026-09-29. [Assessment Scope](https://thegeneralaverage.com/insurance-providers/nationwide/reliability) **Review Score** 7.8 / 10 (4 rated sources). [Review Sources and Method](https://thegeneralaverage.com/insurance-providers/nationwide/reviews) [Insurance for Inland Marine – Nationwide](https://www.nationwide.com/business/insurance/inland-marine/) [+21 more Tools, equipment and inland marine providers](https://thegeneralaverage.com/coverage/inland-marine#documented-providers) Review Scores average eligible source ratings, including approximate BBB grade conversions; they are not pooled customer ratings. [How Reliability Scores Work](https://thegeneralaverage.com/reliability-score). ## Common Questions About Insurance for Medical Devices ### 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. [Quality Management System Regulation (QMSR)](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr), [Overview of IVD Regulation](https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation) [Read the full answer](https://thegeneralaverage.com/industries/medical-devices/does-device-clearance-set-insurance-terms) ### What 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. [Quality Management System Regulation (QMSR)](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr), [Commercial Insurance Guide](https://www.insurance.ca.gov/01-consumers/105-type/95-guides/09-comm/commercialguide.cfm) [Read the full answer](https://thegeneralaverage.com/industries/medical-devices/what-to-disclose-before-first-shipment) ## Verticals Related to Medical Devices - [Consumer Health and Wellness](https://thegeneralaverage.com/industries/consumer-health-wellness): Prepare for a consumer-health launch by describing your data, product claims, devices, and customer relationships in the insurance quote. - [Diagnostics](https://thegeneralaverage.com/industries/diagnostics): Prepare a diagnostics quote around the lab services, result reporting, test products, samples, and equipment your business handles. - [Drug Discovery and Delivery](https://thegeneralaverage.com/industries/drug-discovery-delivery): Prepare for a research contract, an FDA-regulated investigation under an IND, or scale-up by describing your services, sponsor role, materials, and sites. - [Healthcare IT](https://thegeneralaverage.com/industries/healthcare-it): Prepare for a healthcare software contract by mapping health data, customer duties, vendors, and service commitments to the quote. - [Healthcare Services](https://thegeneralaverage.com/industries/healthcare-services): Prepare for a clinic, telehealth launch, or clinician hire by listing services, specialties, sites, staff, and patient-data flows. - [Industrial Bio](https://thegeneralaverage.com/industries/industrial-bio): Prepare for a lab lease or production scale-up by listing biological materials, processes, equipment, sites, and shipments. - [Therapeutics](https://thegeneralaverage.com/industries/therapeutics): Prepare for an FDA-regulated clinical investigation under an IND, a manufacturing agreement, or a first sale by listing sponsor duties, product stage, study roles, and supply partners. ## Sources and Further Reading for Medical Devices - [Quality Management System Regulation (QMSR)](https://www.fda.gov/medical-devices/postmarket-requirements-devices/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](https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-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](https://content.naic.org/cipr_topics/topic_cybersecurity.htm) — National Association of Insurance Commissioners, Center for Insurance Policy and Research. Cyber risk categories and customized-policy qualification - [Cyber Insurance: Cybersecurity for Small Business](https://content.naic.org/sites/default/files/inline-files/cyber-insurance-naic.pdf) — National Association of Insurance Commissioners. First-party and third-party coverage sections; vendor-held data and defense wording prompts - [Commercial Insurance Guide](https://www.insurance.ca.gov/01-consumers/105-type/95-guides/09-comm/commercialguide.cfm) — 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](https://content.naic.org/consumer/small-business.htm) — 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](https://thegeneralaverage.com/editorial-policy). ## Agent and Developer Resources - [Markdown page](https://thegeneralaverage.com/industries/medical-devices.md) - [Developer resources](https://spot.insure/developers) - [Public MCP server](https://spot.insure/mcp) - [MCP server manifest](https://spot.insure/server.json) - [OpenAPI description](https://spot.insure/openapi.json) - [Public page index](https://thegeneralaverage.com/llms.txt)