of US and international quality system requirements, drafting ISO 13485 quality manuals and procedure, conducting gap analyses, pre regulatory audits, preparing Technical Files and Design Dossiers, managing Quality Systems for virtual companies, and communications for

specializes in developing management systems that comply with ISO standards. We provide comprehensive services, including ISO 9001, ISO 13485, FDA Regulatory/ANDA/NDA submissions, as well as ISO 14001, ISO 18001, R2 RIOS, ISO 20000, ISO 27001, and AS9100. Our experienced