Medical Supplies

Mitzpe Aviv Industrial Park 13
20187 M P. Misgav
Israel

Phone: (+972-4)9947880
Fax: (+972-4)9944224
http://www.arazygroup.com
info@arazygroup.com

Company Contacts
Department/ Name Address

Global Mangement benny@arazygroup.com

Company Figures
Number of employees 50-99
Export content > 75%
Year of foundation 1995
Area of business Electronical Equipment / Medical Technology

Laboratory Equipment

Diagnostics

Physiotherapy / Orthopaedic Technology / Occupational Therapy

Services and Publications

Company Profile

CE, FDA, CMDCAS, ISO13485, Autherized Representative
Your organization is probably developing and/or manufacturing top quality medical devices or medical lab equipment. No matter how excellent your products are, the only way the international market will accept them as such is if they have been evaluated by the proper public health authorities and have received the proper regulatory sales clearances.
Since it’s foundation in 1995, the Arazy Group has provided hundreds of international Medical and Lab equipment companies with the professional and specific knowledge and consulting that have lead them to receive marketing approvals such as CE, FDA, CMDCAS, SFDA, KFDA etc’. Many of them have also established and implemented the highest level of Medical Quality Management Systems of the industry, in compliance with FDA QSR, ISO3485:2003 and ISO 9000:2000 and all relevant directives. Need proof? Have a look at our referenced list of international clientele.
Professional regulatory work made simple is The Arazy Group service strategy. Tactically we will provide you with whatever you need! From complete Turn Key projects were we do almost everything for you to ad-hoc limited projects, or just consulting hours.

Product Information
10.10 Technical equipment management, Test houses/Certification Bodies
Regulatory Survey

Do you need a regulatory plan before entering a new market? Do you wish to know what is the best regulatory strategy when launching your product internationally? All you need is ask us to conduct a regulatory survey for you.
What does the regulatory survey report includes?
You will receive from the Arazy Group a report, in which the rather complicated and confusing professional regulatory terms will be detailed in a clear and simple manner. The steps to be taken to get your product approved will be specified to the last detail. The survey will include:

The classification of your product, in Europe, Canada and in the USA.

The route for the required approval in the US (exempt, 510(k), PMA).

The route for the required approval in Europe (ANNEX II, IV, V, VII).

A list of the relevant topics needed to be considered in the application for the approval.

The requirements for medical research (clinical trials), if applicable.

Specific CE or FDA Guidance (if exist), relevant for your specific product.

The requirements of quality control under ISO9001/ISO13485, QSR, Software Validation Standards, and all other requirements applicable to the specific device.

A comprehensive regulatory strategy.

List of services and terms of future collaboration with the Arazy Group.
Please remember:
Regulation of your product is an integral part of the R&D!

It is never too early to start the regulatory process!

The regulatory survey report should be the first step on your path to the market.

Developing a wise and early regulatory strategy will prove, in final analysis, to have been one of the wisest decisions you have taken to get your product sold.