Regulatory Compliance Associates (RCA)
Regulatory Compliance Associates (RCA) – FDA 510(k) & regulatory consulting
Regulatory Compliance Associates can help guide you through any stage of the medical device consulting process, with capabilities during product development through the regulatory clearance/approval of your product. They offer expertise in guiding clients through the medical device consulting process, ensuring adherence to pre/post market information throughout a device's lifecycle.
About
Regulatory Compliance Associates can help guide you through any stage of the medical device consulting process, with capabilities during product development through the regulatory clearance/approval of your product. They offer expertise in guiding clients through the medical device consulting process, ensuring adherence to pre/post market information throughout a device's lifecycle.
Additional information
### **Additional information**
- **Type:** independent
- **Company:** Regulatory Compliance Associates (RCA)
- **Years of experience:** 25
- **510(k)s submitted (self-reported):** 40
- **Location:** US
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** RCA offers medical device consulting services, guiding clients through product development and regulatory clearance/approval. They emphasize adherence to pre/post market information throughout a device's lifecycle.
- **Unique value:** RCA provides end-to-end support for medical device companies navigating the regulatory landscape.
- **Ideal projects:** Medical device companies seeking guidance through the regulatory process, from product development to clearance/approval. Companies that need assistance with pre/post market compliance.
- **Confidence score:** 70/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, de-novo
- **Specialties:** cardiovascular, orthopedic, neurology, radiology, ivd, dental, ophthalmic, general-hospital, anesthesiology, clinical-chemistry, hematology, pathology, software-samd, other
- **Regulatory pathways:** 510k, de_novo, pma, ide, q_sub, hde, post_market, pre-submission, breakthrough_devices, humanitarian_device_exemption
- **Type:** independent
- **Company:** Regulatory Compliance Associates (RCA)
- **Years of experience:** 25
- **510(k)s submitted (self-reported):** 40
- **Location:** US
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** RCA offers medical device consulting services, guiding clients through product development and regulatory clearance/approval. They emphasize adherence to pre/post market information throughout a device's lifecycle.
- **Unique value:** RCA provides end-to-end support for medical device companies navigating the regulatory landscape.
- **Ideal projects:** Medical device companies seeking guidance through the regulatory process, from product development to clearance/approval. Companies that need assistance with pre/post market compliance.
- **Confidence score:** 70/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, de-novo
- **Specialties:** cardiovascular, orthopedic, neurology, radiology, ivd, dental, ophthalmic, general-hospital, anesthesiology, clinical-chemistry, hematology, pathology, software-samd, other
- **Regulatory pathways:** 510k, de_novo, pma, ide, q_sub, hde, post_market, pre-submission, breakthrough_devices, humanitarian_device_exemption
Key Highlights
- RCA offers medical device consulting services, guiding clients through product development and regulatory clearance/approval. They emphasize adherence to pre/post market information throughout a device's lifecycle.
- RCA provides end-to-end support for medical device companies navigating the regulatory landscape.
Certifications & Trust Signals
- 25 years experience
- 40 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- Medical device companies seeking guidance through the regulatory process, from product development to clearance/approval. Companies that need assistance with pre/post market compliance.
HQ:
US
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring, De Novo Strategy & Authoring, PMA Strategy & Support
Pathways Supported:
Traditional 510(k), Special 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
IVD, SaMD, Medical device
Years Experience:
25
Num510k Submitted:
40
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Accepting New Clients:
Yes
