Medical Devices
Coverage built for medical device manufacturers.
Products liability, clinical trials, D&O, cyber, and recall, placed with specialty carriers whose underwriters understand 510(k), PMA, EU MDR, and ISO 13485.
A 30-minute review with a structured gap analysis specific to your segment, not a sales pitch.
02 · Coverage areas
Each program is structured around the specific risk profile of medical devices.
Coverage details, structural considerations, and benchmark guidance for each line are on the page below.
Products Liability Insurance
Coverage for bodily injury and property damage claims arising from medical devices in commerce.
Clinical Trials Liability Insurance
Coverage for bodily injury claims from human subjects participating in medical device clinical trials.
Directors and Officers Insurance
Coverage protecting directors and officers of medical device companies from personal liability for management decisions.
Cyber Insurance
Coverage for data breaches, network security incidents, and cyber-related events affecting medical device companies.
Property and Equipment Insurance
Coverage for facilities, manufacturing equipment, inventory, and specialized R&D equipment used by medical device manufacturers.
Product Recall Coverage
Coverage for the costs of recalling a medical device from market, including notification, retrieval, and disposal expenses.
510(k) and Pre-Market Insurance
Coverage strategy for medical device companies progressing through 510(k) clearance, including liability, D&O, and clinical trial coverage.
Learn
Guides for medical devices.
In-depth coverage explainers written for this segment.
Is Your AI-Powered Medical Device Covered Under Your Current Product Liability Policy?
An AI device keeps changing after it ships. Most product liability policies were written for a device that does not, which leaves post-market updates exposed.
Does Your Business Owners Policy Cover a Medical Device Startup?
Most BOPs exclude medical device companies from eligibility because of product liability. A device startup that buys one finds the exclusion at claim.
How Does a Clinical Trial Affect Your Medical Device Insurance Program?
A device trial is an investigational activity your standard product liability policy was not built to cover. The exposure needs its own clinical trial coverage.
Does Your Commercial Auto Policy Cover a Medical Device Delivery?
Commercial auto covers the vehicle and transit. It does not answer a product liability claim from a delivered device that later causes harm.
What Insurance Does a Contract Research Organization Need?
A CRO running a device study has product, professional, and sponsor-side exposure at once. Programs placed as professional services miss the device risk.
What Insurance Does a Digital Cytology Platform Need?
A digital cytology platform is a lab service and, where AI reads slides, a medical device. Insurance placed as only one of those leaves the other exposed.
03 · Coverage review
Start a review built around your business and stage.
A 30-minute structural review of your current coverage. You receive a gap analysis specific to your segment, stage-appropriate benchmarks, and a working document you can use heading into renewal.