Arazy Group

Arazy Group Canadian Medical Device Regulation CMDCAS approval

Arazy Group Product Compliance Essential Requirements

If you want to know more about regulatory issues of Medical Devices, click here.

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Just take the next 55 seconds to TELL US WHAT YOU NEED, by filing this short form as best as you can and you will get our professional regulatory answers to your inquiry FREE and SHORTLY!!!

Alternatively, you may use the simple “Contact Us” form.

STEP 1 - TELL US WHO YOU ARE

Name: *

E-Mail: *

Company Information

Company Name: *

Type: *

Country: *

URL*: http://

Telephone:*

Note: Fields with * are mandatory.

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Step 1/4

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STEP 2 - TELL US ABOUT YOUR PRODUCTS

What products do you wish to get FDA/CE for?

Product Name	Does it measure? Y/N	Is it Invasive? Y/N	*Continuous time of use()**	Is it Electrical ? Y/N	Is it supplied Sterilized? Y/N
	Yes No	Yes No		Yes No	Yes No
	Yes No	Yes No		Yes No	Yes No
	Yes No	Yes No		Yes No	Yes No

(*) TR: Transient (<60’) – ST: Short Term (>60’ & <30 days) – LT: Long Term (>30 days)
Do similar products exist in the USA? Yes No I dont know
Do you have a Quality Management System? Yes No
Type of Quality Management System that you have:

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Step 2/4

STEP 3 - TELL US YOUR NEEDS

What do you need?

To obtain CE mark and sell our products in EU
To obtain FDA clearance and sell our products in USA
To obtain marketing clearance in other countries
To obtain and implement a Quality Management System in accordance with
To upgrade an existing Quality Management System to
To obtain and implement Medical Software QA and Validation procedures

Do you need any of the following product validations?
Electrical safety EU EMC safety evaluation Software validation Other

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STEP 4 – FINISH AND SEND THE FORM

Additional Information
If you want to complete your information or express any question, please use the following open text space


Please provide the words or the phrases you used when you search on internet for our services (i.e. “CE”, “FDA”, “Regulatory Services”, etc.)

Note: If you use Internet Explorer the free text zone might be restricted to 160 characters. Other navigators do not have this limitation. If you need to send us a longer text, please e-mail it to info@arazygroup.com. Do not forget to mention your contact information in such e-mail. Thank you!
Note: Arazy Group holds, the right to not provide any information if contact name and company indentity can not be verified.

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