Advanced Sterilization Products (Johnson & Johnson)
A&M Biomedical’s commitment to quality, innovation and reliability continues to separate our services from the rest of the field.
Located in Southern California, A&M Biomedical provides process development, manufacturing, supply chain management and distribution services to a wide range of clients and industries including:
“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
“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
Merit Medical
A&M Biomedical’s commitment to quality, innovation and reliability continues to separate our services from the rest of the field.
Located in Southern California, A&M Biomedical provides process development, manufacturing, supply chain management and distribution services to a wide range of clients and industries including:
“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
“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
Vertos Medical
“A&M has consistently exceeded my expectations in many ways. Vertos has found A&M to be extremely compliant with FDA and ISO standards. Second, A&M has reliably delivered on their promises – timing, cost, and quality. Third, A&M has treated us like a partner, allowing full access, promptly notifying us of any issues, and being fully committed to our success – all of these things even when we were a small volume customer!”
David Lalor
Indian Wells Medical
Our company has worked with A&M Biomedical for many years. Our product is difficult to manufacture and carries a Class III designation for its CE mark. A&M Biomedical has always built our manufacturing lots with care and efficiency. They strictly follow ISO 13485 requirements. They have always worked to complete our manufacturing lots in a timely fashion, which is unexpected given that we do not have a regular build plan in place and we often give A&M Biomedical very short notice on our purchase orders. Communication between our Company and A&M has always been great and has helped with scheduling of post-manufacturing operations. We are very happy with the support provided by A&M Biomedical and will continue to work with them for the foreseeable future
Jay Lenker
(Undisclosed Company)
A&M worked with a start up that developed a state of the art 3D dental imaging technology. We worked closely with their engineering team to develop their manufacturing process and quality documentation. A&M’s contributions facilitated the company’s acquisition by the world’s largest dental company.
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.