Medical Device FAQ
Medical Device Insurance Questions, Answered
Each entry below is a buyer-side question device manufacturers ask, with a plain-English answer and links to the medical device practice page and the relevant longer Q&A entry.
How much products liability insurance does a medical device manufacturer need?
How to size products and completed operations for a medical device manufacturer - driven by device class and severity, hospital and GPO contract requirements, and distribution scale rather than revenue alone.
What additional insured status do medical device GPO and hospital contracts require?
Why hospital purchase agreements and GPO contracts require additional-insured for products and completed operations, and why a generic blanket AI endorsement often excludes exactly that.
Does a Class I device need the same insurance as a Class III device?
How FDA device classification (Class I, II, III) affects the insurance program - higher-class and implantable devices carry higher severity and drive higher products and umbrella limits.
What insurance does a SaMD (software as a medical device) company need?
Why a software-as-a-medical-device company needs technology E&O and cyber alongside products liability, and how a software failure that causes patient harm can fall between those policies.
Do medical device startups need clinical trial insurance?
When a medical device company needs clinical trial liability - for human clinical studies (IDE trials) - and why general liability and products policies do not respond to trial-subject injury.
Do medical device companies need product recall insurance?
Why the recall extension inside a products policy is often insufficient for a medical device manufacturer, and what dedicated recall coverage funds - notification, retrieval, replacement, and lost profit.
How much umbrella liability does a medical device company need?
How to size umbrella/excess for a medical device company - driven by device severity and the combined limits hospital and GPO contracts require - and what the umbrella does and does not sit over.
What cyber insurance does a medical device company need?
Why a medical device company - especially with connected devices or SaMD - needs cyber liability and technology E&O, and how connected-device exposure differs from a generic manufacturer.
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