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Arazy Group Bank of SOPs includes procedures for most of the manufacturing processes practiced in the MedTech industry under various environmental conditions.

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Arazy Group provide online and/or onsite assistance in preparation of any third party audits and our consultant can escort you at the time of the audit.

Registration renewal is very important to maintain your product sales clearance and registration for as many years as possible. Renewal of product registration is mandatory in many markets and is subjected to a variety of requirements dictated by local authorities.

Arazy Group offer complete third party lab services for medical device packaging and sterilization validation for any device and any risk classification.

Medical device manufacturers and distributors in the domestic as well as the international market is welcome to gain market approval and clearance for their medical devices and IVDs through the expert assistance of Arazy Group's incredible team of market experts, medical device industry analyzers, authorized representatives.

Arazy Group is a leading medical device consultant that provides medical device manufacturers with international acceptance, right product validation, medical device registration, product regulatory and marketing approvals to help them gain market approval for their medical devices and equipment.

Arazy Group is a major global medical device consultant serving a number of medical developers and manufacturers by providing them with professional and specific knowledge and consulting services in launching their products at a global level.

Biocompatibility can be a complex process as many medical devices are made of more than one material. The current leading standard for biological evaluation of medical devices is ISO 10993 at its latest version.

Arazy Group offers unique line of GlobaR - Global Regulatory Hub (Trade Mark) products such as GlobaR Dossier (Trade Mark), GlobaR - One World Process (Trade Mark), GlobaR Submission Center (Trade Mark) and Universal Authorized Representative (Trade Mark).

Medical device and IVD equipment manufacturers mostly operate within the boundaries of a quality system, which complies with one or more of the international harmonized standards. Those systems are subjected to audits as part of the certification process and regulatory compliance. Internal audits performed by external bodies are a great way to control and maintain QMS activities.

Leaders in global medical device consultancy, Arazy Group offers international standard verification and validation services for your medical products in market.

http://www.arazygroup.com - Medical Device Regulatory Services from medical device consultancy experts in North America, Europe, Asia, Africa and Australia.