Medical Device Manufacturing Insurance Coverage Checklist
The coverages a medical device manufacturing business may carry — core, prevalent, and situational — why each matters, and the gap most often missed.
Pull out your current policy and check the box next to any coverage you can confirm is already in place — anything unchecked is worth a quick conversation with your advisor. Coverage checklist for medical device manufacturers, contract manufacturers, and component suppliers. Priorities reflect typical exposure for this class; confirm against your actual devices, customers, and contracts.
Tick each coverage you can confirm you carry — anything left unticked is a good question for your next policy review.
| Have it? | Coverage | Why this business needs it | Priority |
|---|---|---|---|
| Products Liability (Life Sciences) | Covers patient injury claims from devices or components — check for implant, material, and claims-made retro-date limits. | Core | |
| Product Recall | Pays to notify, retrieve, and replace recalled devices — products liability does not. | Core | |
| Commercial General Liability | Covers premises and operations claims at plants and customer sites. | Core | |
| Umbrella / Excess Liability | Adds limits for mass-tort claims; OEM contracts often require high limits. | Core | |
| Clinical Trials Liability | Covers injury to study participants; usually excluded elsewhere. | Prevalent | |
| Errors & Omissions (Contract Manufacturing / Design) | Covers financial loss to OEMs from out-of-spec parts or design work. | Prevalent | |
| Cyber / Privacy Liability | Covers connected-device data, patient information, and ransomware on production systems. | Prevalent | |
| Commercial Property & Business Income | Covers clean rooms, equipment, and income lost while production is down. | Prevalent | |
| Contingent Business Income | Covers income lost when a critical supplier or sterilizer shuts down. | Situational | |
| Directors & Officers / Regulatory | Covers investor suits and FDA-related defense costs. | Situational | |
| Foreign Liability | Needed for devices sold or trials run outside the U.S. | Situational | |
| Workers' Compensation | Required by law; machining, chemical, and repetitive-motion injuries. | Situational |
The coverage gap most often missed
The gap most often missed by medical device makers is long-tail exposure on a claims-made policy. Device injuries can surface years after sale — the Philips CPAP recall covered machines sold over 13 years — and many life sciences policies are claims-made, so a lapse, a new retro date, or an implant exclusion can leave older products uncovered. Component suppliers face the same risk through OEM contracts that push recall costs down the chain. Confirm your retro date reaches back to your first sale, and add recall coverage that matches your OEM contracts.
Send us the checklist and we'll review your medical device manufacturing coverage line by line, then market it across multiple carriers that compete for your account.
Related: Medical Device Manufacturing Insurance · Medical Device Manufacturing Supplemental (apply) · All coverage checklists
Frequently asked questions
What insurance does a medical device manufacturing business need?
The core coverages for a medical device manufacturing business are Products Liability (Life Sciences), Product Recall, Commercial General Liability, Umbrella / Excess Liability. This checklist also lists the prevalent and situational coverages worth considering, with a plain-English note on why each matters.
Is this checklist insurance advice?
No. It is a free educational tool to help you have a more informed conversation with a licensed professional. It affords no coverage and is not insurance, legal, or financial advice — only your actual policy language governs what is and isn't covered.
Can Cory Washington & Co. review my medical device manufacturing coverage?
Yes. Share your checklist and we'll review your program line by line, market your account across multiple carriers, and explain the trade-offs in plain English. Cory Washington & Co. LLC is licensed in all 50 states.
This checklist is a free educational tool from Cory Washington & Co. to help you review your own coverage and have a more informed conversation with a licensed insurance professional. It is general information only — not insurance, legal, or financial advice, and not a recommendation to buy, change, or cancel any policy. Coverage terms, availability, limits, and requirements vary by policy, carrier, and state, and only the language in your actual policy governs what is and isn’t covered. Checking or leaving blank any item above does not indicate that you are adequately insured or under-insured. Using this checklist does not create a client, agency, or fiduciary relationship. Always consult a licensed professional about your specific situation.