Quality and Regulatory Support for Medical Device Start-ups and Small Companies
Based in the San Francisco Bay Area, supporting clients globally.
Quality Management System
Implementation, maintenance, and improvement of ISO 13485 quality systems, covering documentation, remediation, and readiness for audits and inspections.
Regulatory & Submission
Preparation of regulatory submissions and creation, review, and maintenance of technical documentation. This extends to review of labeling, marketing material, product claims, and PRRC‑related activities.
Complaint Handling & Post-Market
Post‑market support activities, including complaint handling, trend analysis, and preparation of post‑market surveillance plans, reports, and related processes.
Other Areas
Support covering clinical documentation, risk management, product development within broader regulatory and quality frameworks.
Who I work with
Typically woking with:
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Medical device companies requiring additional regulatory and quality expertise without full-time hires
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Startups and growing organizations looking for flexible, part-time QA/RA support
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Organizations without fully established in-house QA/RA capabilities
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Teams requiring additional QA/RA back-office or operational support
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Companies preparing for global market access (EU MDR, MDSAP, TGA, and others)
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Organizations preparing for audits, inspections, or certification renewals
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Teams needing remediation support following audit findings or nonconformities