Andrea Dwyer Steiner
Expert Regulatory Affairs Consultant | 20+ Yrs PMA, IDE, 510(k), EU MDR | Global Strategy & Approvals
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.
HQ:
United States
Languages:
English
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), PMA, Pre-Sub / Q-Sub
Device Types Supported:
IVD, SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
21
Num510k Submitted:
50
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
cardiovascular, orthopedic, gastro_urology, obgyn, ivd
Technology Types:
samd, ivd_test, implantable
Accepting New Clients:
No
