Our Services
A&M Biomedical offers medical device outsourcing services with an emphasis on quality and regulatory compliance. Located in Orange County, California, with over 16 years of experience in the medical device industry as a contract manufacturer, we are ideally suited to assist customers in all aspects of Product Design, Process Development and Manufacturing. A&M Biomedical is a high quality solution for companies looking for a production outsourcing option that will deliver the highest quality products with the efficiency of a small company.
Our services include:
- ISO 13485 certification and FDB state license
- Class 10,000 (ISO Class 7) clean room
- Advanced quality and regulatory control system
- Injection molding and engineering management
- Complete supply chain management
- Assembly and packaging
- A full time staff of highly skilled, trained technicians
Advanced Quality and Regulatory Control System
As a FDB registered and ISO 13485 certified medical device manufacturer of sterile and non-sterile devices, A&M Biomedical utilizes a robust Quality Management System to continuously improve our processes and to keep the company and our customers in compliance. We follow established procedures to ensure products are assembled and packaged to specifications and with all documentation completed and reviewed. With 20 plus years of regulatory experience in house, A&M Biomedical is able to assist our customers in all aspects of production documentation and compliance including creating protocols and performing Installation, Operational, and Performance Qualifications, as required.
Engineering and Injection Molding Services
A&M Biomedical has the expertise to help you in every stage of your project. Working with our network of expert engineers and precision molders, A&M Biomedical will take your design and fabricate tooling to create prototypes for initial testing and review. Prototype molds and production molds can be designed and fabricated to run high volume parts in a variety of materials, including tight tolerance silicone elastomers. We will work with the customer to develop the right combination of existing equipment and custom production tooling to assemble your products in a latex free clean room with assemblers, inspectors and an entire team of medical device professionals who take pride in completing a quality product each and every day.
Supply Chain Management
Throughout our long tenure in the medical device outsourcing industry, A&M Biomedical has developed relationships with a select group of suppliers who are experts in their particular fields. With our expertise in supply chain management, we will utilize these supplier relationships to procure raw materials and excellent service at the best price.
Manufacturing Services
At A&M Biomedical, we offer customers our commitment to quality control and regulatory compliance in the manufacturing process, without sacrificing efficiency. Our focused staff is able to rapidly respond to issues or changes as they arise and, with our team approach, obtain the input and approvals needed to keep production on track. This flexibility and responsiveness makes us uniquely suited to accommodate any size production—from short runs and low volume runs to high volume manufacturing. A&M Biomedical is an ideal choice for any company looking to outsource their manufacturing without compromising quality, compliance or efficiency.
Sterilization and Validation Services
A&M Biomedical has alliances with certified sterilization facilities to provide our customers the optimal choice in sterilization processes and services. With input from our customer, A&M Biomedical will establish and manage the sterilization process while ensuring all quality controls and documentation are maintained. We can provide turnkey product validation with all necessary documentation, product sample submissions and quarterly validation requirements.
