20+ years MedTech experience
Contact This Expert MIS Fractional Expert
Anonymous
Lead Consultant, Design Controls & Quality System Management
MIS Fractional
Specialties
An experienced MedTech professional specializing in design controls and quality system management. Available for short-term virtual fractional consulting engagements with OEMs and CDMOs.
Services Offered
Design Controls
Expert guidance on design controls for medical device development and 21 CFR Part 820 compliance.
Quality System Management
QMS implementation and maintenance for FDA and ISO 13485 compliance.
Risk Management
ISO 14971 risk management processes throughout the device lifecycle.
Work With Anonymous
Available for short-term virtual fractional consulting engagements. No long-term commitments required.
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