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.
HQ:
United States
Languages:
English
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Traditional 510(k) Support, Special 510(k) Support, Abbreviated 510(k) Support, Predicate Research & Substantial Equivalence Strategy, 510(k) RTA Remediation / Refuse-to-Accept Fix, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 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
Supports Estar:
Yes
Supports Rta Remediation:
Yes
Provides Submission Project Management:
Yes
