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Medical Device Manufacturer Insurance - Let us find your best coverage - coverage for medical device makers

Medical device makers need specialty products and clinical trial coverage, and carriers look at device class, FDA clearance and quality systems. Send us a few details and we will shop 50+ carriers for your best rate – no cost, no obligation. Prefer to talk? Call 800-616-3490.

Medical Device Manufacturer Quote Request

Applicant Information:

Business Structure (Optional - choose one)

Have these handy

  • Device list and FDA class
  • 510(k) or PMA numbers
  • ISO 13485 certificate
  • Complaint and MDR history

Related coverage

Coverage details

What Medical Device Manufacturer coverage includes

Medical device makers need specialty products and clinical trial coverage, and carriers look at device class, FDA clearance and quality systems.

  • Products liability - Injury claims from device failure or misuse.
  • Clinical trials - Injury to participants in device studies.
  • Product recall - Pulling devices from hospitals and patients.
  • Property and stock - Clean rooms, equipment and finished devices.
  • Errors and omissions - Financial loss from design or software errors.

Good to know: ISO 13485 certification and a clean FDA inspection history help most with pricing, and Class III devices need specialty markets.

Not covered: implanted devices without disclosure, clinical trials unless added and off-label uses on many policies.

Insurance Application:

Medical Device Manufacturer

Required forms

Medical Device Manufacturer Supplemental Application (PDF)

Download, complete and email to info@societiesinsurance.com, or attach it with your quote request.

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Contact details

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