Arazy Group – Medical Device Consultants
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Arazy Group – Latest news on Medical Devices Regulation

Arazy Group – Relevant Articles about Medical Devices Regulation
If you want to know more about regulatory issues of Medical Devices, click here.
 
 
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Please, provide your product information. If possible please indicate a link to a web page where we can learn more about your company and your devices. If your product already has FDA, CE or other sales and marketing cleared please indicate as such.
 
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From the following list please check those subjects of your interest or simply use the text free box at the end of this form.
 
A.   Sales and Marketing clearances
To obtain CE mark and sell our products in EU
To obtain FDA clearance and sell our products in USA
To obtain sales and marketing clearance in other country
To receive ongoing QA/RA consulting services on global regulatory affairs.
 
B.  Quality Management Systems
To obtain and implement a Quality Management System or upgrade an existing one.
To order external compliance audit of your quality system and/or documents by a qualified third party.
To obtain QMS Certification.
 
C.  Medical Device/IVD compliance assistance in:
Compliance Gap Analysis Report.
Risk Management Report.
Electrical safety and/or EMC.
Product packaging and/or labeling.
Software validation.
Cleaning and/or sterilization.
Biocompatibility issues.
Medical Literature review.
Clinical data and/or Research.
 
D.  Complementary Regulatory assistance such as:
Regulatory Authorize Representative/Designated agent services in
After sales Service representative in
EU/USA Certificate of Free Sale.
Registration with the Italian NSIS data base.
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Arazy Group – Medical Device Regulation - What is CE mark and FDA approval? – FAQs
Arazy Group – Medical Device Regulation – Online Products
 
 
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