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ISO 13485 is a quality standard for organisations that design, develop, produce or service medical devices. It is intended to promote harmonisation in the medical device industry and set a basis for quality system regulations worldwide. All requirements of ISO 13485 are specific to organisations providing medical devices, regardless of the type or size of the organisation. Its primary objective is to facilitate harmonized medical device regulatory requirements.
ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.
AEC will assist your organization in ISO awareness training, documentation, implementation, internal auditing and overall process optimization as per ISO 13485 standard. AEC is a result oriented professional training and certification service providers, offering systematic approaches to improve quality and effectiveness of the system and enhance the productivity by offering systematic approaches. Our main objective is to help you and your organization improve profitability, through better utilization of all of your resources
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