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Dale Miller, Lead Consultant, QMS Implementation & Regulatory Compliance

20+ years MedTech experience

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MIS Fractional Expert

Dale Miller

Lead Consultant, QMS Implementation & Regulatory Compliance

SDM Compliance, LLC

Specialties

Regulatory & Quality

Dale Miller, founder of SDM Compliance, LLC, has over 20 years of experience in regulatory compliance and quality management system implementation for medical device companies. He specializes in FDA 510(k)/PMA submissions, ISO 13485 QMS implementation, and audit preparation.

Services Offered

QMS Implementation

Full ISO 13485 quality management system design and implementation.

FDA 510(k) & PMA Submissions

Regulatory strategy and submission preparation for FDA clearance and approval.

Notified Body Submissions

CE marking and international regulatory submissions for global market access.

Audit Support & Preparation

FDA audit preparation, mock audits, and CAPA management.

Work With Dale

Available for short-term virtual fractional consulting engagements. No long-term commitments required.

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