Regulatory Compliance Associates
Regulatory Compliance Associates – FDA Regulatory Consulting for Medical Devices
Regulatory Compliance Associates is a dedicated FDA regulatory consulting firm specializing in medical device companies. Their expertise encompasses comprehensive regulatory pathway assessment, robust ISO 13485 Quality Management System (QMS) consulting, and thorough ISO 14971 risk management.
About
Regulatory Compliance Associates is a dedicated FDA regulatory consulting firm specializing in medical device companies. Their expertise encompasses comprehensive regulatory pathway assessment, robust ISO 13485 Quality Management System (QMS) consulting, and thorough ISO 14971 risk management.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 25
- **510(k)s submitted (self-reported):** 75
- **Location:** EU
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Regulatory Compliance Associates specializes in guiding clients through all stages of the medical device consulting process, from product development to regulatory clearance/approval. They emphasize strict adherence to pre/post market information throughout a device’s life cycle.
- **Unique value:** RCA provides comprehensive medical device consulting services, covering product development through regulatory clearance/approval, with a focus on quality management systems and risk management.
- **Ideal projects:** The ideal client is a medical device company seeking assistance with regulatory compliance, quality management systems, or navigating the regulatory pathway for their device.
- **Confidence score:** 70/100
### **Qualifications & scope**
- **Submission types:** pma, pre-submission, 510k-traditional, 510k-special, de-novo
- **Specialties:** regulatory strategy, risk management
- **Device panels:** general hospital, cardiovascular, neurology, orthopedic, gastroenterology
- **Regulatory pathways:** 510k, pma, de_novo, breakthrough_devices, pre-submission
- **Type:** independent
- **Years of experience:** 25
- **510(k)s submitted (self-reported):** 75
- **Location:** EU
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Regulatory Compliance Associates specializes in guiding clients through all stages of the medical device consulting process, from product development to regulatory clearance/approval. They emphasize strict adherence to pre/post market information throughout a device’s life cycle.
- **Unique value:** RCA provides comprehensive medical device consulting services, covering product development through regulatory clearance/approval, with a focus on quality management systems and risk management.
- **Ideal projects:** The ideal client is a medical device company seeking assistance with regulatory compliance, quality management systems, or navigating the regulatory pathway for their device.
- **Confidence score:** 70/100
### **Qualifications & scope**
- **Submission types:** pma, pre-submission, 510k-traditional, 510k-special, de-novo
- **Specialties:** regulatory strategy, risk management
- **Device panels:** general hospital, cardiovascular, neurology, orthopedic, gastroenterology
- **Regulatory pathways:** 510k, pma, de_novo, breakthrough_devices, pre-submission
Key Highlights
- Regulatory Compliance Associates specializes in guiding clients through all stages of the medical device consulting process, from product development to regulatory clearance/approval. They emphasize strict adherence to pre/post market information throughout a device’s life cycle.
- RCA provides comprehensive medical device consulting services, covering product development through regulatory clearance/approval, with a focus on quality management systems and risk management.
Certifications & Trust Signals
- 25 years experience
- 75 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The ideal client is a medical device company seeking assistance with regulatory compliance, quality management systems, or navigating the regulatory pathway for their device.
HQ:
EU
Languages:
English
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, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), Special 510(k), De Novo, PMA, 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:
general hospital, cardiovascular, neurology, orthopedic, gastroenterology
Accepting New Clients:
Yes
