iso 13485 risk management

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

, ISO 9001:2008, Project Management, Software Metrics, Software Configuration Management, Software Quality Life Cycle, Quality Control, Testing Methodologies, and Risk Management adherence to the standards set forth by CMMI, ISO 9001:2008, and other accreditations. They also employ

processes, certified to CMMI Level 3, ISO 9001:2015 & ISO 27001:2013 standards, empower our businesses tackle their most complex challenges, lower risk and gain an edge over competitors. Raybiztechembedded systems, cloud computing and IT infrastructure management to organizations in the banking & finance, insurance