• Our Capabilities

Client Recommendation

"When we needed to quickly launch a contract manufacturer for a biological product to supplement internal production capacity, we looked at several companies and A&M Biomedical stood out for its people and flexibility.  Regarding people, A&M was able to offer highly qualified professionals in the area of medical device manufacturing that had a "can-do" attitude about the challenging opportunity that we were looking to realize.  Regarding flexibility, A&M has adeptly responded to our needs with quick lead times without sacrificing quality.  Since the initial engagement, A&M has provided an FDA-compliant manufacturing environment while meeting or exceeding their production delivery commitments.  A&M has truly been a pleasure to work with.  The end-result has been that we, with the help of A&M, were able to meet our commitments to our customers."

- David Amuda, Materials Manager at Advanced Sterilization Products

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