Oriel STAT A MATRIX
Oriel STAT A MATRIX – FDA 510(k) & regulatory consulting expert
Oriel STAT A MATRIX specializes in FDA regulatory consulting for medical device companies, focusing on 510(k) submissions and regulatory strategy.
Buyer Snapshot
Best for
- Companies seeking FDA 510(k) submission expertise.
- Life science organizations needing regulatory affairs consulting.
- Teams requiring QA/RA training.
How engagement typically works
- Consulting and auditing services.
- Training programs for internal teams.
Typical deliverables
- Regulatory strategy and guidance.
- Auditing and compliance assessments.
- Training materials and sessions.
Good to know
- Best when requiring specialized FDA 510(k) and broader regulatory support.
HQ:
Washington, EU
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, 510(k) eSTAR Preparation, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, Regulatory Pathway Assessment, Device Classification Support, 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
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
25
Num510k Submitted:
75
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
cardiovascular, radiology
Accepting New Clients:
Yes
Supports Estar:
Yes
Supports Labeling Review:
No
Provides Submission Project Management:
Yes
Engagement Models:
Consulting, Training
