Free One Hour Consult Type Approval
360 Compliance Partners offers global product type approval and certification services for 100 + countries. Our specialty is electrical and electrical mechanical products including telecommunications, radio, RF, WiFi, Bluetooth, Zigbee, mesh, information technology, computer systems equipment, power supplies, appliances, and other specialty client products. We offer total turn key solutions managing everything from testing to regulatory submission, or streamlined options that focus on obtaining the country regulatory type approval. Clear and concise check lists are provided so the client fully understands what is and is not required. Should the client not have a local agent in country we offer local agent service to comply with a country regulatory requirements.
Products must be compliant to country regulatory requirements throughout their life cycle. To ensure this, the processes a manufacturer uses to design, build, distribute and a support the product should embed the right controls in their ISO QMS program. However, in many cases the expertise in regulatory type approval compliance was not participating, or lacked the knowledge of what controls and check points should be present. Process Link (tm) is a proprietary tool that captures these gaps and provides solutions to improve the quality scheme. Process Link (tm) is an interview based approach, with minimum upfront preparation, that focuses on team interactions and roles. It can be done in as few as 8 hours depending on the maturity of the client. Same day results with no waiting for reports or follow-ups. Process Link (tm) is also effective for clients using ODM manufacturing as a simple means to control and manage regulatory compliance at the ODM location.
No manufacturer should ever face a regulatory challenge on their products resulting from missing a key type approval regulation, or one that is being phased in. Knowing the regulatory type approval requirements a product must comply with for each market country is business critical. Our consulting service includes Road-map development that captures all the applicable regulations, itemized by country and specific requirement, and is easy to sort. The scope includes items such as product labeling, manual language, EMC, EMI, Safety, laws and directives for each, etc. When placed under revision control the Road-maps are easily traceable in history. Road-maps clearly show where testing data can be reused from one country to another and where testing costs can be saved.
With over 35 + years of industry experience we have heard most all of the excuses for missing type approval and inadequate ISO quality systems. We know the pitfalls in product type approval and compliance programs as well as how life cycle teams should work together. Our capability includes items such as: regulatory research, customer service intervention, requirements development, developing product compliance programs, providing third party viewpoints, analysis of current processes, determining root causes for problematic issues, managing product compliance teams on an interim basis, etc.
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