Navigating
Medical Device Compliance
Twelve years at FDA, including ten at the Center for Devices and Radiological Health. Oliveri Consulting works with medical device companies to build
Quality Management Systems and software lifecycle processes that are
efficient and satisfy regulatory requirements.
Services
Oliveri Consulting offers four core service areas, each grounded in direct FDA experience.
Quality Management System Development
Building a new QMS or bringing an existing one into compliance with 21 CFR Part 820/QMSR and ISO 13485. This covers the management activities, document control, CAPA procedures, training records, supplier controls, and process improvement required by FDA inspectors and notified bodies.
Regulatory Inspection Readiness
Mock inspections, gap assessments, and preparation sessions to ensure staff at all levels know what to expect and how to respond. Draws directly on ten years of experience at CDRH across pre-market and post-market functions.
Process Improvement (Lean Six Sigma)
Applying Lean Six Sigma and Agile methods to regulatory and operational processes, reducing cycle times, cutting waste, and removing bottlenecks that slow down submissions, complaints, and CAPA closures. As a Certified Master Black Belt, facilitated the team that reduced Early Alert time for potential Class I Recalls from 30 days to approximately 10 days.
Software Quality and Digital Health
Quality assurance for software as a medical device (SaMD) including IEC 62304 software lifecycle compliance, design controls, and verification and validation. Background includes establishing and leading the only FDA software group certified to ISO 9001:2015.
Contact Oliveri Consulting
Whether you are preparing for an FDA or ISO inspection, remediating a 483 observation,
or building your quality management system,
the place to start is a direct conversation about your situation.
About Cathy Oliveri
Cathy Oliveri spent twelve years at FDA, including ten at the Center for Devices and Radiological Health. Before coming to FDA, she held senior roles at TSA and Lockheed Martin, with an early career at IBM and SAS Institute.
Credentials include Lean Six Sigma Master Black Belt, ASQ Certified Quality Auditor, and Agile Certified Practitioner (PMI-ACP). Education: MS in Computer Science from Johns Hopkins,
BA in Statistics from Princeton.