Implants, Instruments, and Software That Keep People Alive.
Protecting device makers, their designs, and the patients downstream
Medical device manufacturers build products that go into, onto, or around the human body — from Class I instruments to implantable and life-sustaining Class III hardware and connected software — and their defining risk is product liability of the highest severity. When a device malfunctions or an implant fails, the result is serious injury or death, and the claims track accordingly. Layered on top is one of the strictest regulatory regimes in American industry: the FDA controls how these products are designed, validated, manufactured, and reported. This is a specialized corner of manufacturing insurance built for how device makers actually get sued and regulated.
Properly structured coverage protects the company, its engineering, and the patients who depend on what it ships.
The Medical Device Manufacturer's Signature Exposures
Product liability is the dominant exposure, and it sits at the severe end of every product class — an implant that fractures, a pump that over-delivers, or a diagnostic that fails can cause catastrophic bodily injury, wrongful death, and multi-plaintiff litigation, with implantable and life-sustaining Class III devices carrying the heaviest weight of all. Recall exposure runs right alongside it: an FDA Class I recall is the most serious category, and withdrawal, notification, and replacement costs climb fast. Modern devices add a software and technology dimension — a firmware defect, an algorithm error in software-as-a-medical-device (SaMD), or a cybersecurity vulnerability in a connected device creates professional and technology E&O exposure distinct from traditional product liability. Biocompatibility and sterility failures, supplier-component defects, and clinical-evaluation liability round out a risk profile where quality-system discipline is inseparable from insurability.
Key Risks in Medical Device Manufacturing
Medical device manufacturers face exposure related to:
A device or implant fails in use and causes serious injury or death
An FDA Class I recall of a marketed device
A design or manufacturing defect traced to the company's process
A software, firmware, or cybersecurity flaw in a connected device or SaMD
A biocompatibility or sterility failure in a patient-contacting product
Off-label or unsupported marketing and labeling claims
A supplier's defective component incorporated into the finished device
Clinical-evaluation and investigational-use liability
The high-severity device failure and the FDA recall are what most define the company.
Core Coverages for Medical Device Manufacturers
A properly built device program typically includes:
Product Liability & Completed Operations — Covers devices and implants that cause bodily injury after delivery, written at high limits because the severity is among the worst of any product class.
Product Recall — Responds to the withdrawal, notification, and replacement costs of an FDA recall, including the Class I category.
Professional / Technology E&O — Addresses design errors, algorithm and SaMD defects, and failures of the software and engineering behind the device.
General Liability — Covers premises and ongoing operations exposure at the facility.
Commercial Property — Covers the building, clean rooms, production equipment, and inventory.
Cyber & Privacy — Protects against device-security vulnerabilities and breaches of protected health information connected to the product.
Workers' Compensation — Provides legally required coverage for employee injury across production and assembly.
Umbrella / Excess Liability — Adds the high excess limits that device severity demands above the primary program.
What's Commonly Overlooked
Device programs are most often weakened by:
Product-liability and excess limits too low for implantable and life-sustaining devices
No technology E&O for software, firmware, and SaMD defects
No cyber coverage for connected-device vulnerabilities and PHI exposure
Recall limits inadequate for an FDA Class I campaign
Contractual liability assumed from distributors and hospital systems not reviewed
The gap that hurts most is inadequate product-liability and excess limits for a high-severity device failure.
Real-World Claim Examples
An implanted device fractures or migrates and injures the patient
An infusion or dosing device malfunctions and over-delivers, causing harm
A firmware or algorithm defect in a connected device produces an unsafe output
The FDA orders a Class I recall and notification and replacement costs mount
A sterility or biocompatibility failure leads to patient infection and litigation
Any one of these can be catastrophic, and a multi-plaintiff device-failure claim can reach well into eight figures.
Regulatory & Safety Context
The FDA governs device makers through the Quality System Regulation (21 CFR 820), now transitioning to the harmonized Quality Management System Regulation (QMSR) aligned to ISO 13485, and through the market pathways — 510(k), PMA, and De Novo — that turn on device classification (Class I, II, or III). Manufacturers must carry Unique Device Identification (UDI), file adverse-event reports under Medical Device Reporting (MDR), and increasingly meet FDA premarket and postmarket cybersecurity guidance for connected devices. Companies exporting to Europe must additionally comply with the EU Medical Device Regulation (EU MDR). Underwriters expect this framework to be in place, and a clean quality system is central to placement.
Why Proper Placement Matters
Device class is the single biggest driver — implantable and life-sustaining Class III hardware is the hardest to place, non-invasive Class I the easiest — and underwriters weigh revenue, the device portfolio and its end use, 510(k)/PMA status, quality-system maturity, recall and adverse-event history, and whether software or connectivity adds E&O and cyber dimensions. Most device risk is written in the excess and surplus lines (E&S) market, where carriers can tailor high limits and severity-appropriate terms. Presenting a disciplined quality system, clear FDA status, and documented design controls is what opens appetite and improves pricing for an inherently high-severity class.
Our Approach
At Cory Washington & Co., we insure device makers around product severity, FDA exposure, and software risk. We size product-liability and excess limits to device class, add professional and technology E&O for design and SaMD, coordinate recall and cyber around FDA and PHI exposure, and place the program in the specialty and E&S markets that understand high-severity devices. We also insure the broader life sciences sector and structure standalone product liability and product recall and contamination and cyber coverage, within the wider manufacturing category.
When your product keeps people alive, product-liability, E&O, and recall coverage are everything — we build them to the severity of the device.
All insurance descriptions on this website are provided by Cory Washington & Co. LLC strictly for general informational purposes. They are not intended to be, and should not be relied upon as, legal, financial, or insurance advice. The information presented is general in nature and does not guarantee the availability, terms, conditions, or scope of any insurance coverage. Actual coverage is determined solely by the specific policy language issued by the insurer and remains subject to underwriting approval. Nothing on this website creates or implies an agent-client relationship, binds coverage, or alters any existing policy. Cory Washington & Co. LLC expressly disclaims any liability for actions taken, or not taken, based on the content provided here. For advice regarding your particular situation, please consult directly with a licensed insurance professional at Cory Washington & Co. LLC or another qualified insurance professional, and always review your policy documents in full.
See the coverages a medical device manufacturing business may carry — core, prevalent, and situational — plus the gap most often missed, in the Medical Device Manufacturing Coverage Checklist.
Complete the Medical Device Manufacturing Supplemental online in a few guided steps, download the fillable PDF, or browse all applications.
Frequently Asked Questions
How do I get medical device manufacturing insurance through Cory Washington & Co.?
Request a quote or contact our team. We start with a short conversation about your operations, analyze your exposures, then negotiate medical device manufacturing insurance across multiple carriers that compete for your account and present options with the trade-offs explained. Cory Washington & Co. LLC is licensed in all 50 states.
What does medical device manufacturing insurance cost?
It depends on your exposure. Medical device manufacturing insurance is priced on factors like your industry, size, prior claims, and the limits and deductibles you select — so two businesses rarely pay the same. We shop your account across competing carriers and present the trade-offs in plain English.
Is medical device manufacturing insurance required?
Whether medical device manufacturing insurance is strictly required depends on your state, your contracts, and your lenders or clients. Even where it is not mandatory, going without it can leave serious financial gaps. We assess your exposure and any contractual requirements, then structure coverage that meets both.
What if another agency has already declined or non-renewed my coverage?
Difficult, specialty, and previously-declined placements are a core part of our work. We access excess & surplus (E&S) and specialty markets that many generalist agencies cannot, and we explain the trade-offs clearly so you can decide with confidence.
Available in all 50 states. See how requirements differ in California, Texas, Florida, New York, or choose your state.