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Skills

  • Compliance Consulting
  • Fda
  • ISO Compliance
  • Medical Device Design
  • Regulatory Audits
  • Design History Files
  • Software Development

Services

  • Medical Device SW Doc Review

    $100/hr Starting at $100 Ongoing

    Dedicated Resource

    Review Medical Device software design history file documents for Good Documentation Practices (ALCOA+), Compliance to 21 CFR 820, ISO 13485:2016, ISO 14971:2019, and IEC 62304. Also reviewed for suitability...

    Compliance ConsultingFdaISO ComplianceMedical Device DesignRegulatory Audits

  • Medical Device Software Procedure Review

    $100/hr Starting at $100 Ongoing

    Dedicated Resource

    Review organizational procedures for Medical Device software life cycles, planning, design inputs, design implementation, design outputs, design verification, design validation, design change, and design...

    Compliance ConsultingDesign History FilesFdaISO ComplianceMedical Device Design

About

Enabling process-friendly, compliant medical device processes and records

I’ve spent over 20 years in Medical Device and Pharmaceutical Quality with a specialization in Medical Device and GxP Software development and validation. I earned both ASQ CSQE and CQA certifications and am a certified ISO 13485:2016 lead internal auditor. I believe that processes and documentation should serve projects, not hold them hostage. I’ve been on over 30 Medical Device projects that have successfully achieved FDA PMA/510k and EU CE submissions.

Work Terms

Work is performed according to US Eastern Time hours and per United States holidays.