Oriel STAT Analysis
FDA 510(k) Regulatory Consulting | Biostatistics & Testing Planning for Medical Devices
Oriel STAT Analysis is a distinguished consulting firm specializing in FDA 510(k) regulatory consulting. With 12 years of dedicated experience, they excel in providing robust biostatistics and meticulous testing planning for 510(k) submissions. Oriel STAT Analysis empowers medical device companies to expertly navigate FDA regulatory pathways, ensuring successful 510(k) clearances. Their expertise spans across device classes I, II, and III, with a particular strength in IVD and other specialized areas, offering critical support for regulatory leads and contributors.
Buyer Snapshot
Best for
- Medical device companies seeking FDA 510(k) submission support.
- Organizations needing regulatory consulting and auditing.
How engagement typically works
- Project-based consulting for submissions.
- Training programs for internal teams.
Typical deliverables
- FDA 510(k) submission strategy and documentation.
- Biostatistics and testing plans.
- Regulatory compliance assessments.
- Training materials and sessions.
Good to know
- Best when requiring specialized biostatistical and regulatory expertise for medical devices.
HQ:
Washington, United States
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Traditional 510(k) Support, Special 510(k) Support, Abbreviated 510(k) Support, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, Pre-Sub / Q-Sub Preparation, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), Pre-Sub / Q-Sub
Device Types Supported:
Medical device
Years Experience:
12
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
ivd, other
Engagement Models:
Consulting, Auditing, Training
Accepting New Clients:
Yes
Supports Estar:
Yes
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Supports Labeling Review:
No
Provides Submission Project Management:
Yes
