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Dale Miller

Lead Consultant, QMS Implementation & Regulatory Compliance.

Dale Miller, a lead consultant at MIS Fractional and the founder of SDM Compliance, LLC, brings over 30 years of experience in MedTech, with a distinguished career at Zimmer Biomet in Corporate Quality Compliance. As a QMS Lead, he provided enterprise-wide guidance to Zimmer sites on Quality System compliance, specializing in the setup of quality management systems and compliant processes for medical device companies. With extensive expertise in FDA (21 CFR Part 820), ISO 13485, MDSAP, and EUMDR standards, Dale ensures robust, scalable QMS frameworks that support global regulatory compliance and operational success. At MIS Fractional, he supports MedTech OEMs and CMOs by designing compliant quality systems, preparing for regulatory interactions, and managing post-market compliance activities. His consulting services include:

  • QMS Setup and Implementation: Design and implementation of quality management systems compliant with FDA (21 CFR Part 820), ISO 13485, MDSAP, and EUMDR, tailored for medical device companies.
  • Compliant Process Development: Setup of compliant processes for design controls, document control, and change management, ensuring regulatory adherence and operational efficiency.
  • QMS Training and Adoption: Virtual training for teams to understand and adopt QMS requirements, fostering a culture of compliance and quality.
  • QMS Gap Assessments: Assessments to identify gaps in existing quality systems, with actionable recommendations to achieve compliance with FDA, ISO 13485, MDSAP, and EUMDR standards.
  • QMS Scalability for Growth: Strategies to scale quality management systems for growing organizations, ensuring long-term compliance and adaptability across global markets.
  • Quality Auditing: Conducting internal and supplier audits to ensure compliance with FDA (21 CFR Part 820), ISO 13485, MDSAP, and EUMDR standards, identifying risks and opportunities for improvement.
  • FDA Inspection: Preparing for and supporting FDA inspections, including pre-inspection audits, documentation reviews, and on-site guidance to achieve successful outcomes.
  • Recalls, FSCA, and Adverse Event Reporting: Managing recalls, Field Safety Corrective Actions (FSCA), and adverse event reporting to comply with FDA and international regulatory requirements, ensuring timely and effective resolution.