DEBORAH MORLEY
Medical Device Regulatory & Clinical Affairs Expert | 30+ Yrs Exp | FDA Submissions | Global Approvals | QMS
Dr. Deborah Morley is a distinguished Regulatory and Clinical Affairs expert with over 30 years of experience in the medical technology industry. She guides startups and established companies through complex regulatory pathways, specializing in strategic planning, PMA, 510(k), and Q-Submission preparation, and clinical trial management. Dr. Morley adeptly navigates global regulatory requirements, fostering strong relationships with agencies like the FDA. Her expertise in Quality Management Systems and scientific acumen make her an invaluable partner for successful medical device commercialization.
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), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
IVD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
30
Num510k Submitted:
3
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
cardiovascular, ivd
Technology Types:
implantable, ivd_test
Engagement Models:
hourly
Accepting New Clients:
No
