Quality and Regulatory Support for Medical Device Start-ups and Small Companies

How I support teams

I add execution capacity in regulatory submissions, technical documentation, as well as quality system implementation, improvement, and other documentation work.

Effective, compliant and execution-driven.

Flexible Support Model

QA/RA support without a full‑time hire commitment.
I step in during submissions, audits, or peak workloads. My work can be project‑based or temporary basis depending on need.

Simple, flexible, and practical.

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Services

Services cover both regulatory and quality activities for medical device companies, delivered on a project‑based or temporary basis. Support is provided in English and Spanish.

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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. Support also includes review of labeling, marketing materials, 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, biocompatibility and verification and validation activities within broader regulatory and quality frameworks.

Who I work with

I typically support:

Medical device startups and small companies
Teams preparing for EU MDR, MDSAP, TGA compliance
Companies implementing or maintaining ISO 13485
Organizations needing additional QA/RA back office support

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