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We remind you that a contribution of the distributors is requested in Post-Marketing Surveillance (PMS) process (as defined in the distributor agreement). PMS activity consists of an organized collection of safety and efficacy data for all marketed-products. Therefore, you would have to fill out a PMS Form for each GRAFTYS product family. The PMS form is not exhaustive and may be completed with additional data (upon Graftys request or according to your assessment). |
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Month | Day | Year | | | |
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| * Reporting Period (year) | | |
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MEDICAL DEVICE INFORMATION |
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MEDICAL DEVICE INFORMATION |
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| * Countries of distribution: | | |
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| Quantity sold for repoting period: | | |
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POST-MARKETING SURVEILLANCE DATA (FOR REPORTING PERIOD) |
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Check and tick the type of collected (or available) data from your Operators, Field sales distributors and Customers (sub distributors and healthcare professional users) about Graftys products and their private labels: |
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* Post-Marketing clinical study (not sponsored by Graftys)? |
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* Investigational study (not sponsored by Graftys)? |
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* Cadaveric case and/or saw bone case? |
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* Customer complaint and/or incident/recall? Customer Complaints, incidents & risk of incidents shall be reported to Graftys with the “Product Complaint Form” as soon as you have been informed of the event (according to the existing legislation and under pain of legal and criminal penalties). |
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Graftys injectable technology: |
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Do you sell the Delivery Gun beside the dose? |
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MEDICAL DEVICE INFORMATION |
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| * Countries of distribution: | | |
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| Quantity sold for reporting period: | | |
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POST-MARKETING SURVEILLANCE DATA (FOR REPORTING PERIOD) |
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Check and tick the type of collected (or available) data from your Operators, Field sales distributors and Customers (sub distributors and healthcare professional users) about Graftys products and their private labels: |
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* Post-Marketing clinical study (not sponsored by Graftys)? |
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* Investigational study (not sponsored by Graftys)? |
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* Cadaveric case and/or saw bone case? |
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* Customer complaint and/or incident/recall? Customer Complaints, incidents & risk of incidents shall be reported to Graftys with the “Product Complaint Form” as soon as you have been informed of the event (according to the existing legislation and under pain of legal and criminal penalties). |
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MEDICAL DEVICE INFORMATION |
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| * Countries of distribution: | | |
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| Quantity sold for reporting period: | | |
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POST-MARKETING SURVEILLANCE DATA (FOR REPORTING PERIOD) |
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Check and tick the type of collected (or available) data from your Operators, Field sales distributors and Customers (sub distributors and healthcare professional users) about Graftys products and their private labels: |
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* Post-Marketing clinical study (not sponsored by Graftys)? |
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* Investigational study (not sponsored by Graftys)? |
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* Cadaveric case and/or saw bone case? |
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* Customer complaint and/or incident/recall? Customer Complaints, incidents & risk of incidents shall be reported to Graftys with the “Product Complaint Form” as soon as you have been informed of the event (according to the existing legislation and under pain of legal and criminal penalties). |
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PROMOTIONAL TOOLS RAGARDING GRAFTYS PRODUCTS (not provided by GRAFTYS) |
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* Have you obtained approval from GRAFTYS f or all your promotional tools (leaflets, posters, website extracts...)? |
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Please send us your tools as soon as possible for approval. |
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* Have you validated all the promotional tools of your own distributors? |
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"Customer Satisfaction Surveys Form" completed? |
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Do you need any information about PMS ? Please send your requests to GRAFTYS by Phone or Email: Phone: +33 (0) 4 42 60 30 00 Email: [email protected] |
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