We are an experienced group of biomedical, mechanical, and electrical engineers in the San Francisco Bay Area offering everything from simple CAD modeling to large scale production. As contract designers and manufacturers we focus on biomedical devices; but have knowledge and interest in assisting in many other industries. Our Services Include: - Device development from concept to regulatory approval, and successful product transfer manufacturing - Documentation in accordance with QSR and ISO 13485 - Proof of concept prototypes development for fund raising or risk evaluation - Class 7 cleanroom for preclinical and clinical builds - Verification and validation testing - On site engineering and management consulting - 3D printing and machining solutions - Quality and regulatory support Our Expertise Includes: - Mechanical and electrical design with software integration - Failure analysis, Biocompatibility and packaging validation - Electrical test management: Safety testing, EMC compliance and MRI testing - Design for injection molded parts and handles - Disposables and reusable product: catheter, surgical, and equipment