• 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
