Lexology
Lexology – FDA 510(k) & Regulatory Consulting
Lexology is a specialized FDA regulatory consultant with 7 years of experience, focusing on providing expert guidance for medical device companies. They excel in navigating complex regulatory pathways, including 510(k) submissions, pre-submission meetings, IDE, and IND applications. Their expertise extends to critical areas such as regulatory submissions, risk management, usability engineering, clinical evaluation reports, and technical documentation.
About
Lexology is a specialized FDA regulatory consultant with 7 years of experience, focusing on providing expert guidance for medical device companies. They excel in navigating complex regulatory pathways, including 510(k) submissions, pre-submission meetings, IDE, and IND applications. Their expertise extends to critical areas such as regulatory submissions, risk management, usability engineering, clinical evaluation reports, and technical documentation.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 7
- **510(k)s submitted (self-reported):** 3
- **Location:** US (Delaware)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** This Lexology page provides legal insights related to FDA regulatory expert opinions. The article likely offers valuable information on the legal aspects of regulatory submissions and expert testimony.
- **Unique value:** Provides legal perspective on the use of expert opinions in FDA regulatory matters.
- **Ideal projects:** Legal professionals or regulatory affairs specialists seeking information on the admissibility and limitations of expert opinions in FDA regulatory contexts would find this resource useful.
- **Confidence score:** 70/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, pre-submission, investigational_device_exemption, clinical-trials
- **Specialties:** regulatory strategy, risk management, usability engineering, clinical evaluation
- **Device panels:** general-hospital
- **Regulatory pathways:** 510k, de_novo, ide, pre-submission
- **Type:** independent
- **Years of experience:** 7
- **510(k)s submitted (self-reported):** 3
- **Location:** US (Delaware)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** This Lexology page provides legal insights related to FDA regulatory expert opinions. The article likely offers valuable information on the legal aspects of regulatory submissions and expert testimony.
- **Unique value:** Provides legal perspective on the use of expert opinions in FDA regulatory matters.
- **Ideal projects:** Legal professionals or regulatory affairs specialists seeking information on the admissibility and limitations of expert opinions in FDA regulatory contexts would find this resource useful.
- **Confidence score:** 70/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, pre-submission, investigational_device_exemption, clinical-trials
- **Specialties:** regulatory strategy, risk management, usability engineering, clinical evaluation
- **Device panels:** general-hospital
- **Regulatory pathways:** 510k, de_novo, ide, pre-submission
Key Highlights
- This Lexology page provides legal insights related to FDA regulatory expert opinions. The article likely offers valuable information on the legal aspects of regulatory submissions and expert testimony.
- Provides legal perspective on the use of expert opinions in FDA regulatory matters.
Certifications & Trust Signals
- 7 years experience
- 3 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- Legal professionals or regulatory affairs specialists seeking information on the admissibility and limitations of expert opinions in FDA regulatory contexts would find this resource useful.
HQ:
US
Languages:
English
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), De Novo, Pre-Sub / Q-Sub
Device Types Supported:
Medical device
Years Experience:
7
Num510k Submitted:
3
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general-hospital
Accepting New Clients:
Yes
