• Life Science - Medical Devices Quote Application Form

  • Broker Information

  • Format: (000) 000-0000.

  • General Information

  • Company Information

  • Have you acquired any companies within the last 5 years?
  • Are you a subsidiary of another company?
  • Have you ever operated under another name?
  • Please provide a breakdown of your gross revenue by country (DOLLAR AMOUNT):
  • Please provide a breakdown of your business activities:
    Rows
  • Please list your 3 largest customers:
    Rows

  • Product Information

  • Please provide a breakdown of your Products:
    Rows
  • Do any of your past or present products contain any of the following Specified Products or Specified Product Categories:

  • Specific products

    • Infusion systems and pumps
    • Latex Gloves
    • Metal-on-Metal implants
    • Mercury
    • Silicone (only when used as part of an implantable medical device)

  • Specified product categories

    • Birth control or Fertility Products
    • Nanotechnology
    • Products specifically designed for pregnant women
    • Surgical mesh used in urogynecology
    • Unapproved goods or products
  • Browse Files
    Drag and drop files here
    Choose a file
    Cancelof
  • Are all of your products approved for their intended purpose by the relevant regulatory body in the territory in which they are to be distributed?
  • Have any of your products been subject to a medical device adverse incident?
  • Do you contract out product development, manufacturing, sales or distribution services?
  • Are any of your products sold under other's labels or as components of other's products?
  • Are any of your components imported?
  • Are any of your products required to be sold sterile?
  • Do you provide training on the use and/or maintenance of your products?
  • Do you provide maintenance and repair services?
  • Do you sell your products or services via the internet?
  • If Yes, has the website content been reviewed by legal counsel?
  • Do you plan to introduce new products or services within the next 12 months?

  • Regulatory & Compliance Information

  • To the best of your knowledge are you currently in compliance with all applicable government regulations?
  • Have any of your products been subject to an inquiry or been investigated by any regulatory authority?
  • Have any of your products been recalled, withdrawn or discontinued due to a safety or performance reason; initiated by you or a regulatory authority?
  • Have all your manufacturing locations been inspected by the relevant regulatory authority?
  • Has your manufacturing license ever been withdrawn?

  • Risk Management Information

  • Do you have a formal quality control program in place?
  • Do you have a formal recall plan in place?
  • Do you have a system for documenting incident reports and/or complaints?
  • Do you maintain samples of your products?
  • Do you follow Good Manufacturing Practices (GMP)?
  • Are you ISO registered?

  • Are all contracts reviewed by legal counsel concerning the following:

  • a) Contractual Liability
  • b) Product Labeling
  • c) Product Guarantees
  • d) Promotional Materials
  • e) Instruction Manuals
  • f) Copyright
  • g) Trademark
  • h) Registered Design

  • For all products which you are a distributor:

  • a) Do you receive a certificate of products liability insurance from the manufacturer?
  • b) Are you added to the manufacturer's policy as an additional insured?
  • c) Do you retain right of recourse against the manufacturer?
  • Do you require certificates of insurance from all suppliers and sub-contractors?

  • Premises Information

  • Do you store any hazardous substances on your premises?
  • If Yes, are you in compliance with all applicable laws regarding hazardous materials handling and disposal?
  • Have you ever had a biohazard release?
  • If Yes, are you in compliance with all applicable laws regarding hazardous materials handling and disposal?
  • Do you have any laboratory animals on your premises?

  • Clinical Trials (complete only if coverage is required)

    • Please attach the following for each clinical trial to be covered:
      • Protocol (if final version is not available please submit Draft or Synopsis)
      • Informed Consent Form
  • Browse Files
    Drag and drop files here
    Choose a file
    Cancelof
  • Do you conduct Phase 1 and/or Planned Emergency Use Trials?

  • Do you require cover for a research subject who is:

  • a) Pregnant at the time of or during the course of the clinical trial or pre-trial assessment
  • b) Under the age of 18 years at the time of the clinical trial or pre-trial assessment
  • c) Incapable of giving their legal consent to participate in the clinical trial
  • d) A prisoner
  • e) An employee of yours or of the investigator
  • Please provide details of trials performed in the last 12 months:
    Rows
  • Please provide details of active & anticipated trials for the next 12 months
    Rows
  • Are all of your clinical trials approved by the appropriate regulatory authorities?
  • Are all trial subjects required to sign an informed consent form?
  • Do you require all informed consent documents be readable at a Grade 8 level or below?
  • Have you discontinued any clinical trial over concerns about the potential health risks to trial subjects?
  • Have any of your clinical trials been suspended or cancelled by Health Canada or equivalent local authority?
  • Do any of your researchers own more than 15% stock in the Company?

  • Coverage Requirements

  • Coverage Requirements
    Rows

  • Loss Information

  • Has your Company ever had a written demand or civil proceeding for damages made against them?
  • If Yes, please provide the following details on a separate sheet:
    • Date of claim
    • Claimant's name
    • Nature of claim
    • Amount of indemnity payment and amount of defense costs
    • Final dispositions or current status of claim
  • Browse Files
    Drag and drop files here
    Choose a file
    Cancelof
  • Are you aware of any circumstances that might give risk to a claim?

  • Insurance History

  • Is your Company currently insured?
  • If Yes, please complete the table below for the past 3 years:
    Rows

  • Has any insurance company ever:

  • a) Declined your application for insurance?
  • b) Refused to renew any insurance policy?
  • c) Cancelled any insurance policy?
  • Please include the following with the application:
    • Current product list
    • Advertisements, brochures, descriptive literature
    • Sample Service Contracts & Indemnification Agreements
    • Clinical Trial Protocols and Patient Informed Consent Forms (if applicable)
    • Senior staff curriculum vitae
  • Browse Files
    Drag and drop files here
    Choose a file
    Cancelof
  • The completion and submission of this application to the Company does not constitute a promise to provide coverage or a binder of insurance. If the information provided in this application should change between the date of the application and the effective date of the policy, the undersigned warrants that they will immediately report such changes to the insurer. The completion and signing of this application does not constitute a promise to provide coverage. However, if a policy is issued, this application shall serve as the basis of such contract and will be attached to, and form part of the policy.
  • THE UNDERSIGNED HEREBY ACKNOWLEDGES THE TRUTH OF THE STATEMENTS CONTAINED HEREIN. I AUTHORIZE YOU TO COLLECT, USE AND DISCLOSE PERSONAL INFORMATION AS PERMITTED BY LAW, IN CONNECTION WITH YOUR COMMERCIAL INSURANCE POLICY OR A RENEWAL, EXTENSION OR VARIATION THEREOF, FOR THE PURPOSES NECESSARY TO ASSESS THE RISK, INVESTIGATE AND SETTLE CLAIMS, AND DETECT AND PREVENT FRAUD, SUCH AS CREDITINFORMATION, AND CLAIMS HISTORY.
  • For purposes of the Insurance Companies Act (Canada), this document was issued in the course of Lloyd's Underwriters' insurance business in Canada.
  • Should be Empty: