Elexes
Elexes – Expert FDA 510(k) & Regulatory Consulting for Medical Devices
Elexes is a specialized consulting firm dedicated to FDA 510(k) regulatory consulting, providing expert support for startups and established medical device companies. They offer comprehensive assistance with 510(k) submissions and De Novo applications, guiding clients through complex FDA regulatory pathways to achieve successful clearances. Serving clients globally, Elexes enhances the regulatory journey for medical device innovators.
About
Elexes is a specialized consulting firm dedicated to FDA 510(k) regulatory consulting, providing expert support for startups and established medical device companies. They offer comprehensive assistance with 510(k) submissions and De Novo applications, guiding clients through complex FDA regulatory pathways to achieve successful clearances. Serving clients globally, Elexes enhances the regulatory journey for medical device innovators.
Additional information
### **Additional information**
- **Type:** firm
- **Company:** Elexes
- **Years of experience:** 12
- **510(k)s submitted (self-reported):** 25
- **Location:** United States (Maine)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Elexes, represented by Team Elexes, focuses on providing guidance and tools for companies preparing for FDA inspections, particularly in the context of 21 CFR 820 and QSIT compliance. Their mock FDA inspection guide aims to help companies identify and correct gaps before regulatory audits, understand the correlation between inspections, scores, and audit performance, and apply industry best practices.
- **Unique value:** Elexes offers a mock FDA inspection guide and related services to help medical device companies proactively prepare for FDA inspections and ensure compliance with relevant regulations.
- **Ideal projects:** The ideal client for Elexes is a medical device company, especially SMEs, that are seeking to proactively prepare for an upcoming FDA inspection or audit. They would benefit from a mock audit to identify gaps in their quality system and improve their overall compliance.
- **Confidence score:** 70/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, pre-submission
- **Device classes:** class-i, class-ii
- **Device panels:** radiology, general-hospital, neurology
- **Regulatory pathways:** 510k, de_novo, breakthrough_devices
- **Type:** firm
- **Company:** Elexes
- **Years of experience:** 12
- **510(k)s submitted (self-reported):** 25
- **Location:** United States (Maine)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Elexes, represented by Team Elexes, focuses on providing guidance and tools for companies preparing for FDA inspections, particularly in the context of 21 CFR 820 and QSIT compliance. Their mock FDA inspection guide aims to help companies identify and correct gaps before regulatory audits, understand the correlation between inspections, scores, and audit performance, and apply industry best practices.
- **Unique value:** Elexes offers a mock FDA inspection guide and related services to help medical device companies proactively prepare for FDA inspections and ensure compliance with relevant regulations.
- **Ideal projects:** The ideal client for Elexes is a medical device company, especially SMEs, that are seeking to proactively prepare for an upcoming FDA inspection or audit. They would benefit from a mock audit to identify gaps in their quality system and improve their overall compliance.
- **Confidence score:** 70/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, pre-submission
- **Device classes:** class-i, class-ii
- **Device panels:** radiology, general-hospital, neurology
- **Regulatory pathways:** 510k, de_novo, breakthrough_devices
Key Highlights
- Elexes, represented by Team Elexes, focuses on providing guidance and tools for companies preparing for FDA inspections, particularly in the context of 21 CFR 820 and QSIT compliance. Their mock FDA inspection guide aims to help companies identify and correct gaps before regulatory audits, understand the correlation between inspections, scores, and audit performance, and apply industry best practices.
- Elexes offers a mock FDA inspection guide and related services to help medical device companies proactively prepare for FDA inspections and ensure compliance with relevant regulations.
Certifications & Trust Signals
- 12 years experience
- 25 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The ideal client for Elexes is a medical device company, especially SMEs, that are seeking to proactively prepare for an upcoming FDA inspection or audit. They would benefit from a mock audit to identify gaps in their quality system and improve their overall compliance.
HQ:
United States
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), De Novo
Device Types Supported:
Medical device
Supports Rta Remediation:
Yes
Years Experience:
12
Num510k Submitted:
25
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
radiology, general-hospital, neurology
Engagement Models:
fixed_fee
Accepting New Clients:
No
