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Quality Management

System Registered to

ISO 9001 ISO 13485

COMPLIANCE: HAZARDOUS AREAS

Regulatory compliance is a necessary aspect of many designs intended to be used and sold around the world.  Hazardous areas compliance involves the approval of equipment that is intended to operate in an environment that may contain explosive gasses or combustible dusts. Tangent has experience in designing compliant equipment for IECEx, ATEX, and CSA hazardous area classifications. 

 

Recently, Tangent compliance specialists were tasked with providing a certification path for a design of a specialized analyzer that had previously been certified for general purpose operations. Tangent begins all compliance analysis activities with a short period of gathering system information. This involves general device inspection, bill of materials generation or analysis, identification of all potential hazards, and drawing generation or review. After the initial package is produced, Tangent’s compliance team will select all appropriate standards and begin a detailed clause by clause review of the specific compliance standard. The outcome of the clause by clause review is a detailed assessment of the product and an identification of all compliance risks. With this information in hand, our client can decide on the best mitigation strategy (part replacement, redesign, etc) to reduce the risk of noncompliance. 

 

Compliance is necessary in most products, but should not be seen as a barrier for market entry.  Tangent’s compliance team can take the lead in pre-compliance analysis, and also in working with regulatory agencies to achieve a successful product certification.

 

Device regulatory compliance: Problem Solved