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Continual improvement Program
Quality Management System
Manufacturer Name (on which the certification need to be done)
Manufacturer Address with legal entity (on which the certification need to be done)
Contact Person (S)
Contact Number (S)
Email Address (S)
Product Generic Name
Brand Name for product
Are we applying CE Certification for the 1st time
When the product was 1st placed in the market
Intended use of device
Purpose to use the device (Mechanism of Action)
Diseases & Condition where the product can be used
On which patient population Product should be used for eg. paediatric
At which part of body the product can be used
How long product can be in contact with body
Less than 60 mins
Between 60 mins to 30 days
More than 30 days
Product reusable or Single use
Countries where product are placed
Condition where the product should not be used or extra care should be taken (Precaution)
Warnings while using the Product
Material used for device (Material of Construction) Kindly provide their MSDS, COA, testing reports
Does product emit radiation? If yes, what kind?
Manufacturing Flow chart of product
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Principal of Operation of product (Surgical Techniques)
Do product is sterile? If yes kindly provide the sterilization method.
Does product incorporates a medicinal substance /animal tissues, or blood components
Whether the device is intended to cover medical needs that are otherwise unmet
Is there medical alternatives to the device
Competitor companies having CE mark
Is product based on predecessor devices
State of Art (related to product)
Common word used for the product.
Specific product literature available from manufacturer
Design dossier for product with actual image of product
Product contain software? if yes, kindly provide version of software, model name, off the self legacy?