• Our Capabilities

Our Capabilities

A&M Biomedical offers medical device manufacturing solutions with an emphasis on quality and regulatory compliance. With over 20 years of experience in the medical device industry as a contract manufacturer, we are ideally suited to assist customers in all aspects of Process Development, Manufacturing, Quality Control, Packaging and Compliance. A&M Biomedical is a high quality solution provider for companies looking for a production outsourcing option, who they trust to deliver quality products with the efficiency of a small company.

Our capabilities include:

  • ISO 13485 Certification
  • FDA Registration Class 10,000 (ISO Class 7) clean room
  • Quality control and regulatory compliance
  • Engineering services
  • Complete supply chain management
  • Manufacturing
  • Assembly and packaging
    • Prototypes
    • R&D, Pilot and Clinical Trial builds
    • Process verification and validation
    • Full-scale manufacturing of systems
  • Sterilization and validation

Capability