ICON plc
★★★★★
3.0
/ 5
•
18 reviews
ICON plc – Expert FDA 510(k) & Medical Device Regulatory Consulting
ICON plc's medical device & IVD regulatory experts offer a deep understanding of applicable regulations and requirements, extending beyond published guidance to help clients navigate complex global landscapes. They specialize in ensuring compliance and facilitating market access for a wide range of medical technologies.
About
ICON plc's medical device & IVD regulatory experts offer a deep understanding of applicable regulations and requirements, extending beyond published guidance to help clients navigate complex global landscapes. They specialize in ensuring compliance and facilitating market access for a wide range of medical technologies.
Additional information
### **Additional information**
- **Type:** independent
- **Company:** ICON plc
- **Years of experience:** 15
- **510(k)s submitted (self-reported):** 45
- **Location:** CA
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** ICON plc provides regulatory affairs consulting for medical devices and IVDs, helping clients navigate complex regulations and requirements. Their expertise extends beyond published guidance, offering a deep understanding of applicable regulations.
- **Unique value:** ICON plc offers in-depth regulatory expertise for medical devices and IVDs, going beyond standard guidance to provide comprehensive support.
- **Ideal projects:** The ideal client is a medical device or IVD company seeking regulatory guidance and support to gain market access. They would benefit from ICON plc's expertise in understanding and navigating complex regulatory landscapes.
- **Confidence score:** 75/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pma, investigational_device_exemption, de_novo
- **Specialties:** ivd, regulatory strategy, quality management systems, risk management
- **Device panels:** ivd
- **Regulatory pathways:** 510k, pma, de_novo, ide
- **Type:** independent
- **Company:** ICON plc
- **Years of experience:** 15
- **510(k)s submitted (self-reported):** 45
- **Location:** CA
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** ICON plc provides regulatory affairs consulting for medical devices and IVDs, helping clients navigate complex regulations and requirements. Their expertise extends beyond published guidance, offering a deep understanding of applicable regulations.
- **Unique value:** ICON plc offers in-depth regulatory expertise for medical devices and IVDs, going beyond standard guidance to provide comprehensive support.
- **Ideal projects:** The ideal client is a medical device or IVD company seeking regulatory guidance and support to gain market access. They would benefit from ICON plc's expertise in understanding and navigating complex regulatory landscapes.
- **Confidence score:** 75/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pma, investigational_device_exemption, de_novo
- **Specialties:** ivd, regulatory strategy, quality management systems, risk management
- **Device panels:** ivd
- **Regulatory pathways:** 510k, pma, de_novo, ide
Key Highlights
- ICON plc provides regulatory affairs consulting for medical devices and IVDs, helping clients navigate complex regulations and requirements. Their expertise extends beyond published guidance, offering a deep understanding of applicable regulations.
- ICON plc offers in-depth regulatory expertise for medical devices and IVDs, going beyond standard guidance to provide comprehensive support.
Certifications & Trust Signals
- 15 years experience
- 45 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The ideal client is a medical device or IVD company seeking regulatory guidance and support to gain market access. They would benefit from ICON plc's expertise in understanding and navigating complex regulatory landscapes.
HQ:
CA
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
Device Types Supported:
IVD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
15
Num510k Submitted:
45
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
ivd
Accepting New Clients:
Yes
