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Andrea Dwyer Steiner — 510(k) & PMA Consultant (Cardiovascular/Orthopedic)

Founder & Principal Regulatory Affairs Consultant

An accomplished Regulatory Affairs professional with over 21 years of distinguished experience in navigating medical device regulations, Andrea Dwyer Steiner excels in authoring submissions and developing regulatory strategies.

Experience: 21+ years

Submissions: 50 510(k), 10 De Novo, 15 PMA

Expertise & Specializations

Regulatory Pathways

510(k)PMAIDEQ-SubPost-market

Device Specialties

CardiovascularOrthopedicGastro UrologyObgynIVD

Regions Served

Andrea Dwyer Steiner provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)Asia-Pacific

Credentials & Recognition

Education & Credentials

Possesses a Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices from Northeastern University, building a strong foundation in regulatory principles. Holds a Bachelor of Science in Microbiology & Immunology from the University of Miami, providing a valuable scientific and biological understanding crucial for medical device and pharmaceutical regulations. This academic background equips them with comprehensive knowledge to tackle complex regulatory challenges in the medtech industry.

Professional Experience

An accomplished Regulatory Affairs professional with over two decades of experience, holding senior roles at prominent companies including MedLogics International, Stryker, Medtronic, and Becton Dickinson. Demonstrated expertise in developing and executing global regulatory strategies for a wide array of medical devices, from Class II to Class III. Proven ability to lead cross-functional teams, manage complex submissions, and drive timely approvals across US, EU, and APAC markets. Extensive experience authoring critical regulatory documents such as PMAs, IDEs, 510(k)s, and EU MDR files, consistently ensuring compliance and market access.

Former Big MedTech RA Leader
Enterprise experience

Executive Summary

Professional Overview

An accomplished Regulatory Affairs professional with over 21 years of distinguished experience in navigating medical device regulations, Andrea Dwyer Steiner excels in authoring submissions and developing regulatory strategies.

Core Specializations

Regulatory Pathways

510(k)PMAIDEQ-SubPost-market

Device Specialties

CardiovascularOrthopedicGastro UrologyObgynIVD

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.
FDA Mock Audit
Pre-inspection preparation, mock FDA audits, and readiness assessments to ensure compliance before official FDA inspections.
ISO 14971 Consulting
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.
Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
510(k) Authoring & Submission
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.
De Novo & PMA Strategy
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.
QMS Setup & Implementation
Quality management system design, implementation, and validation to meet FDA and ISO requirements.
Post-Market Support
Post-market surveillance, adverse event reporting, and ongoing regulatory compliance support.

Cruxi Independent Snapshot

Best suited for

  • • MedTech companies seeking expert regulatory guidance

Experience signals

  • Regions: US, EU, APAC
  • Background: 21+ years of regulatory experience.

Cruxi view

With 21 years of experience and a Master's degree in Regulatory Affairs, this consultant specializes in navigating complex medical device regulations, authoring critical submissions, and developing strategic regulatory plans. Their expertise spans PMA, IDE, 510(k), and EU MDR files, alongside comprehensive CMC supplements. They possess a proven ability to lead and mentor regulatory teams, driving success and fostering a culture of regulatory excellence for innovative medical products. Notably, they have a strong track record of successfully authoring and submitting numerous PMAs, IDEs, 510(k)s, and EU MDR files, leading to timely approvals for diverse medical devices. Their technical competencies include proficiency in regulatory submissions, CMC supplements, and FDA pre-submission meetings. This consultant's unique combination of FDA experience, device expertise, and regulatory depth makes them particularly valuable for medtech companies.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.

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