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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:

A&M began working with J&J in 2011 producing biological indicators for ASP’s hydrogen peroxide sterilization systems. At peak, we produced 150,000 units/week. Our manual process had superior quality control with yields averaging >97% compared to their automated process yields of 75%

“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

“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

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:

In 2015, Cianna Medical partnered with A&M for the manufacture of their SCOUT® radar localization devices used in the diagnosis and treatment of breast cancer. The SCOUT® system is the first non-radioactive, wire-free breast localization system and the world’s only technology to utilize RADAR in human tissue. In 2019, Merit Medical acquired Cianna and continues to rely on A&M’s years of SCOUT® experience and manufacturing expertise.

“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

“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

Vertos Medical

Also in 2015, A&M started assembling and packaging the mild® Device Kits for Vertos Medical. The mild® Device Kit is a safe and minimally invasive outpatient procedure for treatment of lumbar spinal stenosis (LSS) designed to restore space in the spinal canal through a small incision. A&M has been its sole manufacturing partner and is currently supporting their development activities.

“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

VP of Operations, Regulatory Affairs and Quality Assurance

Indian Wells Medical

A&M has worked with IWM for more than 8 years on the manufacture of their Steerable Transseptal Needle (STSN). This device is used in conjunction with a transseptal introducer to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access. It is a complicated Class III device that requires detailed manual assembly and terminal sterilization.

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

Ph.D., Founder, President & CEO

(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.

Tony Viole

Director of Product Development and Operations Dental Imaging