Regulatory and Quality Assurance

Our dedication to safety and effectiveness is evident in our adherence to regulatory and quality standards, as well as our commitment to QDC.

Regulatory and Quality Assurance

Ensuring global regulatory and quality compliance is deeply ingrained in our corporate culture and mission. With over 20 years of expertise, we adhere to rigorous protocols mandated by the markets we serve, throughout every facet of our manufacturing processes. This unwavering commitment guarantees our customers’ peace of mind, knowing they receive products that are both safe and effective.

Our Quality Policy

We are dedicated to providing safe and effective products and services which meet both regulatory and industry standards. Through compliance to our Quality Management System, utilization of state of the art technologies whenever possible, and adherence to our corporate program for Quality, Delivery, and Cost (QDC), we ensure success throughout each stage of the design, development, manufacturing and commercialization process.

Our Commitment Through Our People and Our Processes

We prioritize continuous improvement and global compliance, focusing on enhancing our products, processes, and services through international and third-party audits for system review. Our dedicated team ensures regulatory and quality assurance for both medical and non-medical products.

  • Compliance to international standards (ISO/FDA) and best practices (GMP).
  • Consistent implementation of our Quality Management System (QMS).
  • Strict adherence to global design control processes, production planning, and document controls.
  • Vendor and Supplier Audits and Management.
  • Manufacturing to Total Quality Management (TQM) processes.

Global Regulatory Registration and Compliance

Our global Quality Management System spans all our facilities and follows the highest international standards. At APS, we proudly comply to the following standards:

  • FDA Registered as a Manufacturer, Contract Manufacturer, Contract Sterilizer, Foreign Exporter, Repackager/Relabeler
  • ISO 13485:2016 Medical devices – Quality Management Systems, Currently Scheduled for Certification in 2024