<html> <body> Bill Ditty </body> </html>

Bill Ditty

VP, Quality Management System Consulting

William (Bill) Ditty has more than 2 decades of experience as a highly accomplished and results-oriented quality assurance executive, with extensive global expertise in strategy development and deployment, regulatory compliance, risk management, program and project management, and audits and inspections. Prior to working in the medical device industry, quality, and regulatory, Bill served as a commissioned officer in the US Coast Guard.

Bill has years of experience in FDA inspections, quality, and regulatory compliance, including creating a regulatory compliance program and implementing a mock FDA inspection program to proactively remediate issues prior to inspection. He has implemented global quality systems from the ground up (MDSAP, EU MDR, etc.), led transition and remediation projects, and has technical working knowledge of many medical device groups, including software and connected medical devices, orthopedic, neurology, ear / nose / throat, implantables, and radiology.

Bill at a Glance

Audit Expertise

  • 21 CFR 820/803/806
  • 21 CFR Part 11
  • ISO (EN) 13485
  • ISO (EN) 14971
  • ISO 9001
  • EU MDD and MDR
  • MDSAP (all countries)
  • China and India

QMS Process Expertise

  • PREMARKET
    • Design Control
    • Document Control
    • Technical File/Documentation
    • ISO 14971/Risk Management
    • IEC 62366/Human Factors
    • IEC 62304/Software Validation
    • ISO 10993/Biocompatibility
    • ISO 11135/Sterilization
    • IEC 60601/Electrical Requirements for Medical Device
  • PRODUCTION
    • ISO 14971/Risk Management
    • Process Validation
    • Production and Process Controls
    • Supplier Controls
    • Document Controls
  • POSTMARKET
    • ISO 14971/Risk Management
    • CAPA
    • Complaint Handling and Medical Device Reporting
    • Supplier Controls
    • Document Controls
    • Postmarket Surveillance
    • FDA 483 Remediation
    • FDA Warning Letter

Education

  • MBA, Finance
  • BS, Naval Architecture & Marine Engineering

The Oriel STAT A MATRIX consulting team averages 25+ years of life sciences industry experience and has deep expertise in US, European and global RA/QA requirements.

Bill’s Areas of Expertise

  • Quality Management Systems – Developed and led a global quality management system (US, EU, India, Asia, etc.,) and created key performance indicators with continuous improvement in all areas of quality assurance, including CAPA and complaint handling, design transfer, production and process controls, risk management, and validation.
  • Auditing – Has lead auditor experience in the EU and MDSAP (US, Australia, Brazil, Canada, and Japan) regulations as well as in China, India, and beyond, with a focus on risk- and process-based auditing, internal audits, baseline and preassessments, and supplier audits.
  • Training – Is a recognized expert in delivering quality and / or regulatory classroom training, as well as developing course materials and content for global training programs.
  • Regulatory – Has experience with 510(k) submissions, Medicare reimbursement, and clinical trials (IDE).

Highlighted Experience

  • Created regulatory compliance program, leading 15 global sites to register with FDA and ensure compliance with all applicable federal, state, and local laws.
  • Hosted 21 FDA inspections (126 audit days), with average observations well below the FDA published average, including eight inspections with zero observations (and hosted additional inspections in the EU and Asia).
  • Served as executive member of a medical device start-up and oversaw quality assurance of Class I, II, and III medical devices in the US and Canada.
  • Product experience includes software as a medical device (SaMD) and connected medical devices.

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