Stephen Chan
Medical Device Regulatory Affairs & QA Consultant | 4+ Yrs Exp | FDA 510(k) Submissions | Startups
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 fillers, photo therapy devices, novel sonography devices, and vital signs devices.
About
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 fillers, photo therapy devices, novel sonography devices, and vital signs devices.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 4
- **Regions served:** US
- **Client types:** startup
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** Stephen's unique value lies in his focused experience with successful 510(k) clearances for startups, combined with his accessible hourly pricing, making him an ideal partner for early-stage medical device companies seeking efficient and cost-effective regulatory guidance.
- **Ideal projects:** The ideal project for Stephen would involve a Class I or Class II medical device company, particularly a startup, seeking 510(k) clearance for a device in the dental, general hospital, software as a medical device (SaMD), or orthopedic space. Companies needing assistance with DHF development, regulatory assessments, or crafting a comprehensive regulatory strategy would also benefit greatly. Projects involving traditional or special 510(k) submissions are a strong fit, allowing Stephen to leverage his proven experience in these areas.
- **Confidence score:** 70/100
- **Last analyzed:** Sun Dec 14 2025 01:11:52 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, qms
- **Device classes:** class-ii, class-i
- **Specialties:** regulatory strategy, software-samd, orthopedic, general-hospital, dental
- **Device panels:** general-hospital, dental
- **Regulatory pathways:** 510k
- **Type:** independent
- **Years of experience:** 4
- **Regions served:** US
- **Client types:** startup
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** Stephen's unique value lies in his focused experience with successful 510(k) clearances for startups, combined with his accessible hourly pricing, making him an ideal partner for early-stage medical device companies seeking efficient and cost-effective regulatory guidance.
- **Ideal projects:** The ideal project for Stephen would involve a Class I or Class II medical device company, particularly a startup, seeking 510(k) clearance for a device in the dental, general hospital, software as a medical device (SaMD), or orthopedic space. Companies needing assistance with DHF development, regulatory assessments, or crafting a comprehensive regulatory strategy would also benefit greatly. Projects involving traditional or special 510(k) submissions are a strong fit, allowing Stephen to leverage his proven experience in these areas.
- **Confidence score:** 70/100
- **Last analyzed:** Sun Dec 14 2025 01:11:52 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, qms
- **Device classes:** class-ii, class-i
- **Specialties:** regulatory strategy, software-samd, orthopedic, general-hospital, dental
- **Device panels:** general-hospital, dental
- **Regulatory pathways:** 510k
Key Highlights
- 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 stron
- Stephen's unique value lies in his focused experience with successful 510(k) clearances for startups, combined with his accessible hourly pricing, making him an ideal partner for early-stage medical device companies seeking efficient and cost-effective regulatory guidance.
Certifications & Trust Signals
- 4 years experience
Buyer Snapshot
Best for
- The ideal project for Stephen would involve a Class I or Class II medical device company, particularly a startup, seeking 510(k) clearance for a device in the dental, general hospital, software as a medical device (SaMD), or orthopedic space. Companies needing assistance with DHF development, regulatory assessments, or crafting a comprehensive regulatory strategy would also benefit greatly. Projec
HQ:
United States
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, Predicate Research & Substantial Equivalence Strategy
Pathways Supported:
Traditional 510(k), Special 510(k)
Device Types Supported:
SaMD, Medical device
Supports Predicate Research:
Yes
Years Experience:
4
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general-hospital, dental
Engagement Models:
hourly
Accepting New Clients:
Yes
