Coverage checklist
Medical Device Insurance Coverage Review Checklist
Most coverage gaps are found the same way: during a claim, when it is too late to fix them. A short, deliberate review before a renewal catches them while there is still time to act.
This checklist walks a device manufacturer through the points that most often turn out to be misaligned. It is general guidance rather than a substitute for reviewing your specific policies, but it is a useful way to pressure-test a program before you rely on it.
Before your next renewal
Ten points to confirm.
- 1
Confirm Products Liability Covers Software And Updates
Many products forms were written for a device that is fixed at the point of sale. If yours ships patches or updates, confirm the language contemplates software and firmware, not only the hardware as delivered.
- 2
Find The Line Between Cyber And Products Liability
Read the two policies side by side. A connected device that harms a patient through a security failure can fall between a cyber policy that excludes bodily injury and a products policy that ignores software. Confirm one of them clearly answers it.
- 3
Map Connected Devices To Their Postmarket Obligations
For connected devices, FDA cybersecurity expectations create ongoing duties to monitor and address vulnerabilities. Confirm your program and your documentation support those duties for as long as the device is in use.
- 4
Check Recall Coverage And Its Limit Against Units In The Field
Products liability does not pay to retrieve product. Confirm recall coverage exists and that its limit reflects your current footprint, not the smaller one you had when the policy was written.
- 5
Confirm The D&O Limit Reflects Your Latest Financing
Directors and officers exposure scales with capital raised and board composition. A limit set at the last round may no longer match the company, and investors often specify a minimum in the financing terms.
- 6
Verify Clinical Trials Coverage And Its Tail
If you have run or are running studies, confirm the coverage is in force and that a tail is arranged so subject claims that surface after the study closes still have a policy to answer them.
- 7
Align Quality Documentation With The QMSR Transition
Under the current quality system rules, your documentation is the defense in a product liability claim. Confirm it reflects the transition and that your risk records would actually support a defense.
- 8
Review Retroactive Dates And Claims-Made Terms
On a claims-made program, prior acts can fall outside the policy in force when a claim arrives. Confirm the retroactive date reaches back to when the exposure began, especially after any carrier change.
- 9
Read The Insurance Schedule In Every Customer Contract
Hospital, distributor, and contract-manufacturing agreements specify limits, additional insured status, and certificate requirements. Confirm your program actually meets each one, and read the schedule before signing rather than after.
- 10
Confirm Additional Insured Status And Certificates Are In Place
A requirement in a contract only protects you if the endorsement and certificate exist and match the wording. A mismatch is a common reason onboarding stalls or a claim is contested.
Take it with you
Get the checklist as a printable PDF.
A clean, printable version to work through before your renewal or hand to whoever manages your program. No sales follow-up unless you ask for it.
Common questions
Frequently Asked Questions
How Often Should A Device Company Review Its Coverage?
At least annually at renewal, and any time something material changes: a financing, a new product or indication, a distribution or hospital agreement, an FDA milestone, or a move into a new market. Those events are the moments exposure shifts.
What Is The Most Common Gap On This List?
Two recur most: assuming products liability pays for a recall when it does not, and carrying software-enabled devices under language written for fixed hardware. Both are quiet until a claim, and both are avoidable with a review.
Can We Do This Review Ourselves?
You can use this checklist to spot likely gaps, which is worthwhile on its own. Confirming the policy language and the contract requirements line up is where a coverage review with a specialist adds the most value.
Coverage review
Want a second set of eyes on the gaps?
Start a coverage review and we'll work through this checklist against your actual policies and contracts, then respond within one business day.