FISCHER RISK MANAGEMENT / INDUSTRIES
Medical device insurance. Your role matters as much as the device.
Developing, manufacturing, importing, or distributing a device can raise different insurance questions. Start with your role, the device’s use, and the stage your business has reached.
Request an Insurance ReviewA prototype and a product in the field need different questions.
Medical device insurance discussions need a clear description of the company’s role, the device, its intended use, and where it is in development or commercialization. Fischer Risk Management focuses on the business’s commercial insurance program.
Bring the details behind your next move.
Device and business role
Identify the devices, intended users, use settings, and whether you design, manufacture, import, or distribute them. Include outsourced activities and relevant contractual responsibilities.
Development and commercialization
Explain whether products are in development, involved in trials, or sold commercially. Share the current regulatory status and planned changes without assuming one policy addresses every stage.
Connected products and support
Describe software, remote monitoring, data handling, installation, training, and support services where applicable. These details help frame both product and technology insurance discussions.
Connect the policies with the way you operate.
The review may involve product liability, recall, technology errors and omissions, cyber, property, and other commercial coverage. Specific device types, activities, territories, and policy wording must be evaluated before making coverage conclusions.
Review the stage and role of each device
A company developing a device, a contract manufacturer, and a distributor can have different activities and contractual responsibilities. Describe each device's intended use, users, settings, and commercialization stage. Explain trials or studies where applicable, sales territories, outsourced work, and anticipated changes so the insurance discussion starts with the actual business.
