• Compliance Quality Control Services


A FDA registered and ISO 13485 Certified medical device manufacturer of sterile and non-sterile devices, A&M Biomedical utilizes a Quality Management System to continuously improve our processes and to keep our customers in compliance. For each project, we provide assessment in the following areas:

  • Research as to which standards apply
  • Review and redline product specifications for completeness and effectiveness
  • Assist in identification of appropriate sampling plans for receiving, in-process, and final inspections
  • Create MPs, QPs, DTs and MTs to establish customer’s DMR
  • Create protocols and perform installation, operational, and performance qualifications, as required

With 30 plus years of in-house, regulatory experience, A&M Biomedical is able to assist our customers in all aspects of production documentation and compliance.