• Manufacturing Services 2

Client Recommendation

"A&M Biomedical has successfully supported Advanced Sterilization Products, a division of Johnson & Johnson in the clean room manufacturing of our medical device for over 2 years.  A&M has consistently delivered the highest level of quality with lean manual assembly and in-process inspections, in addition to rapidly responded to our changing production demand.  I very much appreciate their exceptional communication to assure alignment to quality, manufacturing processes and specifications to support our customers."

— John Posey, Staff Operations Engineer at Advanced Sterilization Products

Quality - It’s at the Heart of All We Do

At A&M, we take extremely seriously the impact our work has on patients, caregivers, medical professionals and the healthcare industry in general. The key to achieving and sustaining A&M’s long-term success in manufacturing, comes down to the people we choose to be part of our team and making certain they share our commitment to quality.

We demonstrate our commitment to quality by proactively including check points from the process development phase — all the way through our manufacturing and distribution processes. And we consistently monitor outcomes and conduct in-depth analysis of our manufacturing performance, to exceed industry standards for safety and reliability.

As a FDA registered and ISO 13485 certified, medical device manufacturer of sterile and non-sterile devices, A&M Biomedical utilizes a robust Quality Management System to continuously improve our processes and keep our customers in compliance. We have established compliance procedures and invest the necessary time to ensure our finished products are assembled and packaged to our clients’ specifications.

At A&M we don’t just talk about quality, our finished products and reputation in the industry demonstrates this commitment to quality manufacturing.


Reliability - A Pinnacle of Our Success

With over 20 years of solidly focusing on reliability, the A&M Biomedical team consistently takes proactive steps to identify and understand potential vulnerabillities in our manufacturing processes. 

To that end, we have made significant investments in our facility, equipment, and our well-trained and highly-skilled technical team to ensure our finished products meet or exceed our clients' expectations.

  1. Prevention:  We ensure regulatory compliance, robust quality management processes, operational excellence, supply chain security, and business continuity planning.
  2. Training:  We invest whatever amount of time is needed to ensure consistency and high quality from lot-to-lot.
  3. On-Time Delivery:  We adopt a "whatever it takes" approach to make certain our clients' timelines and deadlines are met.  Our response times are unmatched. 

It is our unsurpassed level of commitment to reliability and our ability to consistently achieve a positive experience for our clients that truly separates A&M's medical device solutions from others.

NSAI Certified FDA Logo CA Seal
  • Previous
  • Next

Quality