Audit Preparation & Response

• Prep and response for ISO 13485/MDSAP and ISO 14971; accreditation surveys (URAC, JCAHO); state and federal regulatory audits and reviews • Audit and effectiveness checks in various areas, including regulatory and process compliance, privacy and jurisdictional requirements • SWOT consultation for organizations prepping for regulatory and accreditation audit response • Creation of audit response tools including operationalizing requirements to match an organization’s products, services and operations • Unprecedented results in state survey reviews, CMS validation audits, annual operations reviews and accreditation surveys • Hyper-organized, systematic project management of audit response preparation