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Mike Baca, Lead Consultant, Global Quality Systems & Compliance

20+ years MedTech experience

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MIS Fractional Expert

Mike Baca

Lead Consultant, Global Quality Systems & Compliance

White Rook Consulting, LLC

Specialties

Regulatory & Quality

Mike Baca, founder of White Rook Consulting, LLC, is a global quality systems and compliance expert with over 20 years of medical device experience. He specializes in quality system overhauls, global regulatory strategy, and FDA remediation programs for medical device companies.

Services Offered

Global Regulatory Strategy

Multi-market regulatory strategy for FDA, EU MDR, and international submissions.

Quality System Overhaul

Full QMS assessment, gap analysis, and remediation for FDA and ISO compliance.

CAPA Management

Corrective and preventive action program design and management.

FDA Warning Letter Response

FDA warning letter response strategy and remediation planning.

Work With Mike

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

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