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QUALITY - IT’S AT THE HEART OF ALL WE DO

Medical devices impact all of us—in our own lives or through the lives of our friends and family. They can provide life-saving intervention for a father with heart disease or life improving treatment for a mother with lumbar stenosis. They can restore vision to a grandmother with cataracts or help detect and diagnose breast cancer in a daughter and facilitate early intervention. This perspective is what we keep top of mind in our work at A&M. The devices we build, could be used on someone we love–and will be used on someone who is loved. It is this perspective that drives us to prioritize quality in everything we do. Efficiency is good, but maintaining quality is better.

OUR QUALITY POLICY

A&M Biomedical, with the commitment from management and the participation of all its employees, complies with relevant regulatory requirements, maintains and reviews the effectiveness of the Quality Management System, and manufactures quality products that meet our customer’s requirements.

QUALITY MANAGEMENT PROCESS

ISO 13485 emphasizes risk management, quality control, and continuous improvement throughout the medical device lifecycle. A&M Biomedical’s Quality Management System provides the structure for minimizing risk and ensuring quality in all we do. Our procedures codify customer and regulatory requirements and ensure our processes are performed consistently throughout the company. By establishing metrics, conducting regular audits, and implementing corrective actions, A&M drives ongoing improvement to our QMS. We value the critical impact our QMS has on quality, efficiency, and our ability to meet customer requirements. Our management team understands the success of our QMS is necessary for the success of our customers’ products. As we see it, our services are only as good as our QMS.

RELIABILITY IS OUR REPUTATION

Most A&M customers are repeat customers, or customers who have referred other companies to A&M. To us, there is no higher compliment than to earn the trust of people who know our work. Our customers rely on A&M to efficiently and conscientiously provide quality solutions for their manufacturing concerns.

Prevention:

We ensure regulatory compliance, robust quality management processes, operational excellence, supply chain security, and business continuity planning.

Training:

We invest the necessary time in training to ensure consistency and high quality from lot-to-lot.

On-Time Delivery:

We adopt a "whatever it takes" approach to make certain our clients' timelines and deadlines are met.

“Our company began working with A&M over three years ago, when they became our contract manufacturer for a new product that was nearing development completion. A&M’s experienced team of medical device professionals, an environment that created an open exchange of information and a “partnership” philosophy, were instrumental in enabling us to complete the development of our device. A&M also simultaneously provided, effective processes for product assembly and the work was completed in a very timely manner. With A&M’s support, we were able to respond to clinical and marketing input, requiring design and process changes and still launch the product commercially as expected. A&M’s attention to detail assisted us in improving up-stream quality of components, as well as minimizing the amount of testing, during the integration of the product assembled into our finished system that ships to customers. A&M has also been able to consistently make adjustments and respond to our changing demand, whether it be from component shortages, or varied demand associated with a new product launch. Initially sought out as a contract manufacturer, A&M has now actually became a part of our team.”

Tony Viole

Director of Product Development and Operations Dental Imaging

“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

“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