Michael V. Ward
Expert FDA Regulatory & Clinical Consultant | Driving Medtech Innovation from Strategy to Submission.
Highly accomplished and results-driven Clinical & Regulatory Professional with extensive executive leadership experience in the medical device industry. Dr. Ward possesses a profound expertise in navigating complex regulatory pathways, including FDA [IDE/510(k)/PMA], CE Mark, and other international submissions. He excels in developing robust regulatory strategies, managing global clinical trials, and conducting comprehensive biocompatibility and safety assessments. His proven ability to drive successful outcomes, exemplified by achieving Breakthrough Device Designation for multiple companies and resolving critical FDA concerns, makes him an invaluable asset for medtech companies seeking to accelerate product development and market entry with confidence and efficiency.
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), Special 510(k), PMA
Device Types Supported:
IVD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
16
Num510k Submitted:
50
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
cardiovascular, neurology, radiology, ivd, other
Technology Types:
implantable, ivd_test, combo_product
Accepting New Clients:
No
