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.
About
Oriel STAT A MATRIX specializes in FDA regulatory consulting for medical device companies, focusing on 510(k) submissions and regulatory strategy.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 25
- **510(k)s submitted (self-reported):** 75
- **Regions served:** US, EU
- **Location:** EU (Washington)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Oriel STAT A MATRIX is a consulting firm specializing in FDA 510(k) submissions for medical devices. They have a presence in both the EU and Washington, indicating a broad geographical reach.
- **Unique value:** Oriel STAT A MATRIX provides consulting services for FDA 510(k) submissions, offering expertise in navigating the regulatory pathway for medical devices.
- **Ideal projects:** Their ideal client is a medical device company seeking assistance with FDA 510(k) clearance. This could range from startups to established companies.
- **Confidence score:** 50/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, pre-submission
- **Specialties:** ivd, risk management
- **Device panels:** cardiovascular, radiology
- **Regulatory pathways:** 510k, de_novo, ide, pre-submission, hde
- **Type:** independent
- **Years of experience:** 25
- **510(k)s submitted (self-reported):** 75
- **Regions served:** US, EU
- **Location:** EU (Washington)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Oriel STAT A MATRIX is a consulting firm specializing in FDA 510(k) submissions for medical devices. They have a presence in both the EU and Washington, indicating a broad geographical reach.
- **Unique value:** Oriel STAT A MATRIX provides consulting services for FDA 510(k) submissions, offering expertise in navigating the regulatory pathway for medical devices.
- **Ideal projects:** Their ideal client is a medical device company seeking assistance with FDA 510(k) clearance. This could range from startups to established companies.
- **Confidence score:** 50/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, pre-submission
- **Specialties:** ivd, risk management
- **Device panels:** cardiovascular, radiology
- **Regulatory pathways:** 510k, de_novo, ide, pre-submission, hde
Key Highlights
- Oriel STAT A MATRIX is a consulting firm specializing in FDA 510(k) submissions for medical devices. They have a presence in both the EU and Washington, indicating a broad geographical reach.
- Oriel STAT A MATRIX provides consulting services for FDA 510(k) submissions, offering expertise in navigating the regulatory pathway for medical devices.
Certifications & Trust Signals
- 25 years experience
- 75 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- Their ideal client is a medical device company seeking assistance with FDA 510(k) clearance. This could range from startups to established companies.
HQ:
Washington, EU
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) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, Pre-Sub / Q-Sub Preparation, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, Pre-Sub / Q-Sub
Device Types Supported:
Medical device, IVD, SaMD
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:
No
Supports Labeling Review:
No
Provides Submission Project Management:
Yes
Engagement Models:
Consulting, Auditing, Training
