What services does Stephen Chan offer?

Stephen Chan offers Regulatory Pathway Assessment, 510(k) Submission Authoring, QMS Setup & Implementation and other FDA regulatory consulting services for medical device companies.

What regulatory pathways does Stephen Chan specialize in?

Stephen Chan specializes in 510k and other FDA regulatory pathways for medical devices.

What is Stephen Chan's regulatory experience?

Stephen Chan has 4+ years of experience in FDA regulatory affairs.

Stephen Chan

Regulatory Affairs and Quality Assurance Professional

Experienced Medical Device Regulatory Affairs and Quality Assurance professional with over 4 years of experience supporting startups. Proven success in DHF development, 510(k) submissions, regulatory assessment, and strategy. Led 3 successful FDA clearances for endoscopic and wheelchair devices, and provided regulatory assessments and strategy for Class II to Class III devices including dermal fil...

Experience: 4+ years

Expertise & Specializations

Regulatory Pathways

510k

Device Specialties

General-HospitalDental

Regions Served

Stephen Chan provides regulatory consulting services to clients in:

United States (FDA)

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510k

Device Specialties

General-HospitalDental

Services Offered

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.

QMS Setup & Implementation
Quality management system design, implementation, and validation to meet FDA and ISO requirements.

Cruxi Independent Snapshot

Best suited for

• MedTech companies seeking expert regulatory guidance

Experience signals

Regions: US
Background: 4+ years of regulatory experience.

Cruxi view

Stephen Chan offers a focused expertise in medical device regulatory affairs and quality assurance, particularly valuable for startups navigating the complexities of FDA submissions. His experience leading three successful 510(k) clearances for endoscopic and wheelchair devices demonstrates a proven track record. Stephen's experience with Class II and Class I devices, coupled with his understanding of regulatory strategy for devices like dermal fillers and vital signs monitors, makes him a strong asset for companies seeking efficient regulatory pathways. His hourly pricing structure makes him accessible to startups with limited budgets.

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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