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WHO-GMP/US FDA/MHRA/TGA APPROVALS |
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Approval by international regulatory agencies is a cumbersome task. Although principles of GMP are more or less similar, the approval procedure by each agency is different.
CALGS provides technical support for all international level certifications. The systematic approach adopted by us helps the client to move in a positive direction to achieve certification within estimated time schedule. For this purpose, CALGS has already established tie up with foreign approval agencies. |
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| QUALITY MANAGEMENT SYSTEM: ISO 9001/13485 |
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Certification for ISO 9001: Quality Management System (QMS) and ISO 13485 QMS specific to Medical Devices are essential for all those who would like to market their product globally. |
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CALGS provides support to Medical Device industry in achieving ISO 9001 and ISO 13485.
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CE: MEDICAL DEVICES |
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Marketing of products in European Union and other countries becomes easier once a company receives approval for CE marking of their products. The European Council Directive 93/42/EEC outlines these requirements. Devices are divided into Classes I, IIa, IIb and III in accordance with Annexure IX of the Directive. |
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The conformity assessment procedures for Class I devices can be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of vulnerability associated with these products.
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For Class IIa devices, the intervention of a notified body should be compulsory at the production stage.
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For devices falling within Classes IIb and III which constitute a high risk potential, inspection by a notified body is required with regard to the design and manufacture of the devices.
Class III is set aside for the most critical devices for which explicit prior authorization with regard to conformity is required for them to be placed on the market.
CALGS provides support in preparation for Conformity Assessment, Documentation, Technical File preparation, Pre Audit Assessment, Training and Audit (both Internal and External). |
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