Exceptional ISO 13485 and FDA 21 CFR Quality

Obsessed with quality beyond compliance

The industry's best quality and service is our goal

As a leading provider of high quality, contract manufacturing services to the medical device industry AJR Specialty Products is ISO 13485 compliant and operates under all applicable governing standards and regulations, including FDA 21 CFR Part 820 – The U.S. Quality System Regulation Good Manufacturing Practice for Medical Devices (QSR).

For us, quality is the daily expectation across all day-to-day operations. Exceptional quality is an integral part of our business strategy, and foundational to our business philosophy.

Quality and Regulatory Compliance Units at AJR Group

Our staff of highly trained employees oversees all quality-related functions for AJR Group's manufactured products. In addition, technicians, inspectors, coordinators and administrative personnel daily perform vital functions to assure effective implementation of our quality management system and compliance with applicable regulatory requirements.

Quality and Regulatory Compliance at the AJR Group consists of the following areas:

  • Quality Assurance
  • Quality Control
  • Regulatory Affairs