A&M Biomedical
A&M Biomedical is a medical device solutions provider with over 30 years of experience, specializing in contract manufacturing, supply chain management, and distribution services. Located in Southern California, the company is committed to quality, reliability, and customer partnership, serving a wide range of industries including respiratory, ophthalmic, cardiac, dental, and surgical devices. They emphasize building quality into every process and maintaining compliance with ISO and FDA standards.
Industries
Nr. of Employees
small (1-50)
A&M Biomedical
23042 Alcalde Drive, Suite A, Laguna Hills, CA 92653
Services
Turnkey contract manufacturing for medical devices including manual assembly, packaging, and scale-up from pilot to high-volume production performed in controlled environments.
Assessment and execution of quality and compliance activities including specification review, sampling plan development, creation of manufacturing and quality documentation, and support for regulatory record-keeping.
Management of component sourcing relationships and logistics to support production schedules and product delivery.
Inventory management, storage of finished goods (post-manufacture or post-sterilization), order preparation and shipment per customer specifications.
Turnkey contract manufacturing for medical devices including manual assembly, packaging, and scale-up from pilot to high-volume production performed in controlled environments.
Assessment and execution of quality and compliance activities including specification review, sampling plan development, creation of manufacturing and quality documentation, and support for regulatory record-keeping.
Management of component sourcing relationships and logistics to support production schedules and product delivery.
Inventory management, storage of finished goods (post-manufacture or post-sterilization), order preparation and shipment per customer specifications.
Expertise Areas
- Contract medical device manufacturing
- Quality management and ISO 13485 compliance
- Regulatory compliance (FDA registration, CE support)
- Cleanroom and sterile manufacturing
Key Technologies
- Class 7 cleanroom (HEPA-filtered) environments
- Manual assembly and in-process inspection methods
- Sterilization process coordination
- Prototype tooling and production molds
News & Updates
A&M Biomedical supported Johnson & Johnson's division in clean room manufacturing, producing biological indicators for over 2 years with high quality and responsiveness.
Supported Merit Medical in manufacturing Cianna Medical's SCOUT system and Vertos Medical's mild Device Kits, demonstrating flexibility and quality.
Supported a start-up in developing manufacturing processes for a 3D dental imaging technology, facilitating their acquisition by a major dental company.
A&M Biomedical supported Johnson & Johnson's division in clean room manufacturing, producing biological indicators for over 2 years with high quality and responsiveness.
Supported Merit Medical in manufacturing Cianna Medical's SCOUT system and Vertos Medical's mild Device Kits, demonstrating flexibility and quality.
Supported a start-up in developing manufacturing processes for a 3D dental imaging technology, facilitating their acquisition by a major dental company.