ISO 13485 Quality System Installation

Quality System Installation and Training

Our customers can benefit from the thousands of hours we have invested in quality system design and implementation.  Whether it is supporting the implementation of our own quality system products or developing custom quality system procedures, our goal is to help our customers focus on their products and services  while providing the resources needed to achieve ISO 13485 certification and FDA QSR compliance.

To learn more about how we can help you with your quality system needs please contact us at info@aplyon.com

ISO 13485 Quality Systems for Manufacturers

Medical device quality systems developed for organizations engaged in the development and manufacture of medical devices.

ISO 13485 Quality Systems for Specification Developers

Medical device quality system developed for companies engaged in the design of medical devices but perform no manufacturing
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Quality Systems for Initial Importers of Medical Devices

Medical device quality system designed for organizations engaged in the initial import of medical devices into the United States