Our Quality Policy
American Biosurgical is devoted to being the recognized solutions provider of sterile and non-sterile surgical, diagnostic and patient monitoring cable assemblies to the entire surgical and medical community with exceptional quality, service and timeliness that enables the highest level of patient care.
We strive to exceed our customer's expectations through the combined talents and experience of our personnel and the timely delivery of products and services consistent with our reputation as an industry leader.
We are committed to achieve our goals of customer satisfaction through continuous improvement to maintain a high Quality Management System. American Biosurgical will develop our employees in a positive work environment that fosters creativity, accountability, personal satisfaction, and teamwork.
With partnerships established across the globe, we provide our clients with products manufactured in facilities certified to meet the EN ISO 13485 and ISO 9001 requirements, which follow the FDA cGMP guidelines. When required our medical interconnects and devices are FDA registered. Additionally our products conform to the following standards as applicable:
- ANSI/AAMI EC-53
- ANSI/AAMI HF-18
- IEC 60601
- DIN 42-802
Our testing capabilities for verification & validation and quality control include:
- Biocompatibility testing to medical standards such as ISO 10993-5 & ISO10993-10
- Mechanical: tensile, flex life, impact, connector mate/demate forces & life cycles.
- Electrical: Continuity, Isolation, Capacitance, Impedance, Dielectric strength, Triboelectric Noise, Defibrillation.
- Chemical Analyses
- Custom testing devices and protocols for special applications