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Medical Devices Application

Submission of this information does not represent a binding of any insurance contract or agreement. Additional information may be required in order to get an accurate quote of insurance.

"*" indicates required fields

Business Address*

About Your Organization

Is the business incorporated?*
Do you expect any significant changes to your operations within the next 12 months?*
Examples: New products, New services Expansion, New locations, Acquisitions
Have you ever operated under another business name?*
Have you acquired any businesses, subsidiaries, or related entities within the past 5 years?*
Have you filed for bankruptcy or insolvency protection within the past 10 years?*
Has the company, or any owner, officer, director, partner, or shareholder, been investigated for alleged criminal activity related to the business?
Please list any additional locations not noted above
Street Address
City
Province / State
Postal / ZIP Code
 
Subsidiaries or Related Companies
Company Name
Description of Operations
Relationship to Applicant
 
Examples: Manufacturing, Distribution, Research & Development, Product Design, Consulting, Contract Manufacturing, Clinical Services

Revenue

Please provide your gross revenue by activity.
Revenue Source
Previous 12 Months
Next 12 Months
Manufacturing and Sale of Own Products
Contract Manufacturing of Own Products
Contract Manufacturing for Third Parties
Wholesale / Distribution of Third-Party Products
Repackaging / Relabelling
Retail Sales
Licensing Agreements / Royalties
Research & Development
Consulting Services
Other
Please provide your gross revenue by geographic region.
Region
Previous 12 Months
Next 12 Months
Canada
United States
All Other Countries

Products

Top Selling Products
Product Name
Approximate % of Gross Revenue
 
Medical Device Classification Please indicate the approximate percentage (%) of revenue generated by each device class.
Total Should Equal 100%
Medical Device Categories Please indicate the approximate percentage (%) of revenue generated by each device type.
Total Should Equal 100%
Have any products been on the market for less than 3 years?*
Have any products been recalled or withdrawn within the past 5 years?*
Have any adverse event reports been filed involving your products within the past 5 years?*
Are any products sold under a third-party brand or incorporated into another company's product?*
Are all products approved by the applicable regulatory authorities?
Do you expect to launch any new products within the next 12 months?*
Do you provide clinical services as part of your operations?*
Do employees interact directly with patients, consumers, or end users?*

Requested Insurance Coverage

1. Commercial General Liability & Product Liability*
Provides coverage for eligible claims alleging bodily injury or property damage arising from your business operations and products, subject to the policy’s terms, conditions, and exclusions.
2. Errors & Omissions / Professional Liability*
Provides protection for claims alleging financial loss resulting from professional services, advice, research, consulting, testing, design, or other professional activities performed by your organization. Coverage is subject to policy terms, conditions, exclusions, and any retroactive date requirements.
3. Medical Malpractice / Professional Healthcare Liability*
May provide protection for claims arising from healthcare, clinical, medical, scientific, laboratory, or related professional services provided by qualified personnel. Coverage availability depends on the nature of services provided and underwriting approval.
4. Clinical Trials Liability (Optional)
May provide protection for claims arising from approved clinical trial activities involving study participants. Coverage is subject to underwriting review, study protocols, jurisdictional requirements, and policy terms and conditions.
May provide protection for claims arising from approved clinical trial activities involving study participants. Coverage is subject to underwriting review, study protocols, jurisdictional requirements, and policy terms and conditions.
5. Product Recall Expense (Optional)
May help reimburse certain expenses associated with the withdrawal, recall, replacement, inspection, communication, or disposal of products when a covered recall event occurs. Coverage varies significantly by insurer and policy wording
6. Cyber Liability (Optional)
May provide protection for claims arising from approved clinical trial activities involving study participants. Coverage is subject to underwriting review, study protocols, jurisdictional requirements, and policy terms and conditions.
May provide protection for claims arising from approved clinical trial activities involving study participants. Coverage is subject to underwriting review, study protocols, jurisdictional requirements, and policy terms and conditions.
7. Property Insurance (Optional)
May provide coverage for buildings, tenant improvements, equipment, inventory, laboratory contents, and other insured property against specified causes of loss. Coverage is subject to policy terms, valuation provisions, exclusions, and deductibles.
8. Equipment Breakdown (Optional)
May provide coverage for sudden and accidental mechanical or electrical breakdown of eligible equipment, including certain laboratory, manufacturing, refrigeration, and production equipment. Coverage is subject to policy conditions and exclusions.
9. Crime Coverage (Optional)
May provide protection for certain losses resulting from employee dishonesty, theft, fraud, forgery, funds transfer fraud, or other covered criminal acts. Coverage varies by policy and insurer.
10. Directors & Officers Liability (Optional)
May provide protection for claims arising from approved clinical trial activities involving study participants. Coverage is subject to underwriting review, study protocols, jurisdictional requirements, and policy terms and conditions.
May provide protection for claims arising from approved clinical trial activities involving study participants. Coverage is subject to underwriting review, study protocols, jurisdictional requirements, and policy terms and conditions.
11. Environmental / Pollution Liability (Optional)
May provide protection for certain liabilities arising from pollution conditions, contamination events, cleanup costs, or environmental damage where coverage is specifically provided under the policy. Coverage is subject to underwriting review and policy wording.
May provide protection for certain liabilities arising from pollution conditions, contamination events, cleanup costs, or environmental damage where coverage is specifically provided under the policy. Coverage is subject to underwriting review and policy wording.

Additional Coverage Information

If requesting a claims-made coverage (such as Errors & Omissions, Medical Malpractice, Clinical Trials Liability, Cyber Liability, Directors & Officers Liability, Environmental Liability, or similar), please indicate the current retroactive date, if known:
MM slash DD slash YYYY
Have these coverages been maintained continuously from the retroactive date(s) indicated above?

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