Our Certifications

ISO Certificate

ISO 13485 determines prerequisites for a quality administration framework where an association needs to exhibit its capacity to provide clinical gadgets and related services that reliably meet client and pertinent administrative necessities. Such associations can be engaged with at least one phases of the life-cycle, including design and improvement, production, stockpiling and distribution, establishment, or overhauling of a clinical gadget and plan and advancement or arrangement of related activities.

ISO 13485 can likewise be utilized by suppliers that provide product, including quality administration framework related administrations to such associations.

CE Certificate

The Européenne Conformité (CE) Mark is mandatory for regulating the products marketed within the European Economic Area (EEA) since 90’s.

The CE marking basically depicts the manufacturer’s declaration that products are in compliance with the EU’s New Approach policy.

These directives are applicable to the products within the EU and also for those companies who are involved in manufacturing of the product.