Compliance 360 Consulting LLC Expertise

Our expertise and personal brand is what gives us a competitive advantage.

With 25+ years of Medical Device Industry experience in Global Quality Management System (QMS) and Quality System Regulation (QSR) leading QMS implementation, integration and remediation and hand-on, big picture thinker unique skills set

In depth expertise in Project Management, PostMarket Surveillance and Risk Management, with Product design and development, Systems Integration and Clinical Validation background, as well as natural ability to lead teams and share expertise, we will make your Company success our personal goal. We will work together to ensure that Quality and Compliance is your mind set going forward.

Whenever you work with Compliance 360 Consulting, you can trust that you’re in great hands

Core Expertise

Medical Device Class I-III and Combination Products Experience
Quality Management and Regulatory Compliance
Risk Management Integration, ISO 14971
Medical Device Reporting (MDR/MDV)
Implantable | IVD | Medical Imaging
Complaints Management and Remediation
Field Corrective Action & Recalls
PostMarket Surveillance
ISO 13485, ISO 9001
EU MDR/IVDR
QSR/NPD Activities
Quality Data Review and Trending
Risk Acceptability Analysis
Program/Project Management
Corrective Action/Preventive Actions (CAPA)/NCR Procedures/CRB Management
Global Logistics and Distribution
SmartSolve, TrackWise, SAP, Salesforce, Tableau, QAD/CEBOS, MS Excel, Minitab
Lean Six Sigma Certified
MSCE/MBA – Masters of Computer Engineering/Master of Business Administration (MBA)

Core Competencies

Strong Leadership – Effectively Leading global teams, able to build confidence in others
Ability to influence without authority
Managing and measuring work
Creative problem solver and change agent who is looking for faster and better ways
Effective communication and collaboration skills
Ability to review, analyze, summarize, and interpret data, draw conclusions and make appropriate recommendations and decisions, write reports and give oral presentations.
Trending quality data, presenting internally as well as at external conferences
Process/Project/Program Management
Continuous Process Improvement – Change champion and/or core team member in multiple process improvement initiative