COMPLIANCE & QUALITY CONTROL
A FDA registered and ISO 13485 Certified medical device manufacturer of sterile and non-sterile devices, A&M Biomedical utilizes a Quality Management System to continuously improve our processes and to keep our customers in compliance. For each project, we provide assessment in the following areas:
- Review and redline product specifications for completeness and effectiveness
- Assist in identification of appropriate sampling plans for receiving, in-process, and final inspections
- Create MPs, QPs, DTs and MTs to establish customer’s DMR
- Create protocols and perform installation, operational, and performance qualifications, as required
With 30 plus years of in-house experience, A&M Biomedical is able to assist our customers in all aspects of production documentation and compliance.
QUALITY AND RELIABILITY
A&M Biomedical is a medical device, solutions provider offering contract manufacturing, supply chain management and distribution. Our commitment to quality and reliability is why clients turn to us and keep returning to us for their manufacturing needs.
“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
“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
“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.”