MCRA
MCRA – Expert FDA Regulatory Consulting for Medical Devices
MCRA is a dedicated FDA regulatory consulting firm specializing in supporting medical device companies. With extensive expertise, they offer comprehensive guidance and implementation strategies for a wide range of FDA submissions, ensuring clients navigate the regulatory landscape effectively.
About
MCRA is a dedicated FDA regulatory consulting firm specializing in supporting medical device companies. With extensive expertise, they offer comprehensive guidance and implementation strategies for a wide range of FDA submissions, ensuring clients navigate the regulatory landscape effectively.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 15
- **510(k)s submitted (self-reported):** 75
- **Location:** US
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** MCRA is a regulatory advisor for the medical device and biologics industries. They offer advice and implementation strategies for FDA submissions.
- **Unique value:** Leading U.S. Regulatory Advisor for the Medical Device and Biologics industries.
- **Ideal projects:** Medical device and biologics companies seeking assistance with FDA regulatory submissions and strategies.
- **Confidence score:** 75/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pma, investigational_device_exemption, de_novo
- **Specialties:** regulatory strategy, quality system implementation, clinical trials, risk management, usability engineering
- **Device panels:** cardiovascular, orthopedic, general_surgery, neurology, gastroenterology, ophthalmic
- **Regulatory pathways:** 510k, de_novo, pre-submission, ide, pma, breakthrough_devices
- **Type:** independent
- **Years of experience:** 15
- **510(k)s submitted (self-reported):** 75
- **Location:** US
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** MCRA is a regulatory advisor for the medical device and biologics industries. They offer advice and implementation strategies for FDA submissions.
- **Unique value:** Leading U.S. Regulatory Advisor for the Medical Device and Biologics industries.
- **Ideal projects:** Medical device and biologics companies seeking assistance with FDA regulatory submissions and strategies.
- **Confidence score:** 75/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pma, investigational_device_exemption, de_novo
- **Specialties:** regulatory strategy, quality system implementation, clinical trials, risk management, usability engineering
- **Device panels:** cardiovascular, orthopedic, general_surgery, neurology, gastroenterology, ophthalmic
- **Regulatory pathways:** 510k, de_novo, pre-submission, ide, pma, breakthrough_devices
Key Highlights
- MCRA is a regulatory advisor for the medical device and biologics industries. They offer advice and implementation strategies for FDA submissions.
- Leading U.S. Regulatory Advisor for the Medical Device and Biologics industries.
Certifications & Trust Signals
- 15 years experience
- 75 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- Medical device and biologics companies seeking assistance with FDA regulatory submissions and strategies.
HQ:
Washington D.C., US
Languages:
English
Timezones:
UTC, EST
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring, Medical Device Reimbursement, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device, IVD, Combination product
Supports Rta Remediation:
No
Supports Predicate Research:
Yes
Years Experience:
18
Num510k Submitted:
100000
Ex FDA:
Yes
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
Orthopedics, Digital Imaging, Neuro-musculoskeletal, Radiology
Technology Types:
AI/ML enabled medical devices, Radiologic AI tools, Medical imaging
Accepting New Clients:
Yes
Supports Estar:
No
Supports Labeling Review:
No
Provides Submission Project Management:
Yes
Engagement Models:
Full-service, Component-based
