ALKU
ALKU – Expert FDA 510(k) & Regulatory Consulting for Medical Devices
ALKU is a dedicated FDA regulatory consulting specialist for medical device companies. Their comprehensive services encompass ISO 13485 Quality Management System (QMS) consulting and essential regulatory support to ensure compliance and facilitate market access.
About
ALKU is a dedicated FDA regulatory consulting specialist for medical device companies. Their comprehensive services encompass ISO 13485 Quality Management System (QMS) consulting and essential regulatory support to ensure compliance and facilitate market access.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 5
- **510(k)s submitted (self-reported):** 3
- **Location:** US
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** ALKU provides medical device consulting expertise in quality & compliance, technical engineering & validation, regulatory, clinical, & medical affairs, & software & technology. They deliver methodology and resources to ensure compliant, effective, & efficient execution of quality system requirements.
- **Unique value:** ALKU specializes in providing a variety of medical device talent & solutions across the medical devices & diagnostics industry.
- **Ideal projects:** The ideal client is a medical device or diagnostics company seeking talent and solutions to meet quality system requirements and navigate the regulatory landscape.
- **Confidence score:** 70/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, pma, investigational_device_exemption, pre-submission, annual_reports
- **Specialties:** risk management
- **Device panels:** general hospital, cardiovascular
- **Regulatory pathways:** 510k, pma, ide, de_novo
- **Type:** independent
- **Years of experience:** 5
- **510(k)s submitted (self-reported):** 3
- **Location:** US
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** ALKU provides medical device consulting expertise in quality & compliance, technical engineering & validation, regulatory, clinical, & medical affairs, & software & technology. They deliver methodology and resources to ensure compliant, effective, & efficient execution of quality system requirements.
- **Unique value:** ALKU specializes in providing a variety of medical device talent & solutions across the medical devices & diagnostics industry.
- **Ideal projects:** The ideal client is a medical device or diagnostics company seeking talent and solutions to meet quality system requirements and navigate the regulatory landscape.
- **Confidence score:** 70/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, pma, investigational_device_exemption, pre-submission, annual_reports
- **Specialties:** risk management
- **Device panels:** general hospital, cardiovascular
- **Regulatory pathways:** 510k, pma, ide, de_novo
Key Highlights
- ALKU provides medical device consulting expertise in quality & compliance, technical engineering & validation, regulatory, clinical, & medical affairs, & software & technology. They deliver methodology and resources to ensure compliant, effective, & efficient execution of quality system requirements.
- ALKU specializes in providing a variety of medical device talent & solutions across the medical devices & diagnostics industry.
Certifications & Trust Signals
- 5 years experience
- 3 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The ideal client is a medical device or diagnostics company seeking talent and solutions to meet quality system requirements and navigate the regulatory landscape.
HQ:
US
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), De Novo, PMA
Device Types Supported:
Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
5
Num510k Submitted:
3
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general hospital, cardiovascular
Accepting New Clients:
Yes
