RKM Quality Assurance

Quality Policy

R.K. Manufacturing Corp. is committed to providing quality products and services to the medical device industry that exceeds the expectations and needs of our customers. We are committed to complying with regulatory requirements and maintaining the effectiveness of our quality management system.

Our Mission

R.K. Manufacturing Corporation’s mission is to provide its customers with consistently high quality and to provide a competitive edge to support our customer’s positions in the health care market.

Quality Values and Beliefs

  • Outstanding service to our Customers
  • Innovation, quality, and value in our products
  • Respect for our customers, suppliers, employees and community
  • Creativity and teamwork in the workplace
  • Honesty and integrity in all that we do


  • Registered by BSI for ISO 13485 Medical Device Manufacturing
  • Registered by BSI for ISO 9001Quality Management Systems
  • FDA Registered Manufacturing facility, Registration number # 1226146
  • Compliant with Medical Device Directive (MDD) 2007
  • Compliant with 21CFR Part 820, (current Good Manufacturing Practice)

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