Diego Rua
DRX2 Consulting, LLC
Ph.D. Scientific & Regulatory Consultant | Biomedical Expertise | Big Data Analysis | FDA Regulatory Affairs. https://drx2consulting.com/
An accomplished scientific consultant with a Ph.D. in Molecular & Cellular Biology and an M.B.A. with a concentration in Strategic Management. He boasts over 26 years of experience in biomedicine and big data analysis, with expertise in performing safety and toxicological assessments, reviewing pre-clinical and clinical studies, and evaluating post-market surveillance data for FDA-regulated products.
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), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
IVD, Medical device
Supports Estar:
No
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Supports Labeling Review:
No
Provides Submission Project Management:
No
Years Experience:
35
Num510k Submitted:
50
Ex FDA:
Yes
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
general_surgery, dental, ivd, wearable_digital, cardiovascular, orthopedic
Technology Types:
ivd_test, wearable_patch, implantable, combo_product
Accepting New Clients:
No
