Protecting Innovation in Medical Technology
Medical device manufacturers in California operate at the intersection of innovation and responsibility. Whether you produce surgical tools, diagnostic equipment, wearable monitors, or implantable devices, you’re working in a high-stakes, highly regulated industry. One defect, breakdown, or claim could result in major financial or legal consequences.
What’s Included in Medical Device Manufacturing Insurance?
Each medical technology company has a different risk profile. Your coverage can be structured to include:
General Liability Insurance – Covers third-party claims related to bodily injury or property damage due to your premises or operations
Product Liability Insurance – Critical for device manufacturers, this protects against claims of malfunction, injury, or failure related to your products
Professional Liability (Errors & Omissions) – Protects against errors in device design, consultation, or regulatory missteps
Commercial Property Insurance – Covers your clean rooms, labs, testing facilities, raw materials, and final products
Workers’ Compensation Insurance – Required in California for injuries caused during manufacturing or testing
Equipment Breakdown Insurance – Essential coverage for high-precision machines and diagnostic tools
Cyber Liability Insurance – Protects sensitive patient and proprietary data involved in connected or smart devices
Business Interruption Insurance – Covers income loss during recall events or regulatory shutdowns
You can bundle several of these protections into a Business Owners Policy (BOP) for simplified, cost-effective coverage.
Why Medical Device Manufacturers in California Need Insurance
The risk profile for this sector is intense. Here are a few challenges your policy will help mitigate:
Product Recall Costs: Recalls can be triggered by FDA rulings, compliance audits, or consumer safety concerns.
Lawsuits for Malfunction or Misuse: Even FDA-approved devices can lead to injury claims if used improperly or with undetected flaws.
Equipment Downtime: Precision manufacturing equipment is costly to repair and vital to daily output.
Property Damage: Fire, water damage, or natural disasters can destroy valuable research, materials, or production tools.
Regulatory Fines or Violations: Insurance can help cover legal fees associated with compliance violations.
Explore more risk-specific solutions through our Manufacturer Insurance California or General Liability Insurance California pages.
Frequently Asked Questions
Is product liability coverage mandatory for medical device manufacturers?
It’s not legally required, but highly recommended due to the life-impacting nature of medical devices.
Does the policy include coverage for product recalls?
Yes—product recall insurance can be added to cover notification, shipping, disposal, and public relations.
Do I need cyber insurance if I don’t store patient data?
Yes, especially if your devices are cloud-connected or IoT-based, which may expose your systems to breaches.
What if we contract out part of the manufacturing process?
You still hold liability for the final product. The policy can extend coverage to subcontracted operations if disclosed.
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Still Have Questions?
Whether you’re expanding your floor space or integrating new robotic automation, let’s make sure your insurance grows with your operation. Our team works closely with manufacturers across California to deliver scalable coverage that protects your shop now—and into the future.