HELPING YOU FIND YOUR WAY TO QUALITY AND REGULATORY SUCCESS
 
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Experienced in Quality, Regulatory & Clinical Compliance for Medical Device, Pharmaceutical, Biologics, In Vitro Diagnostics, ISO 9001:2015, Automotive & Aerospace

QUALITY SYSTEM ASSESSMENT & AUDITING

Finding Gaps & Opportunities

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QMS DEVELOPMENT & IMPROVEMENT

Value Beyond Compliance

EDUCATION & TRAINING

Know, Don't Guess

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REGULATORY INTERACTION SUPPORT

Preparation, Response, and Remediation

PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE

Satisfying EU PRRC Requirements

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CLINICAL/PERFORMANCE EVALUATION REPORTS

CER / PER Authoring & Review

 

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