Sharlin Consulting
Sharlin Consulting – Expert FDA Regulatory & 510(k) Consulting
Sharlin Consulting is a dedicated FDA regulatory consulting firm specializing in supporting medical device companies through their regulatory journey. With extensive experience, they offer expertise in navigating complex FDA requirements.
About
Sharlin Consulting is a dedicated FDA regulatory consulting firm specializing in supporting medical device companies through their regulatory journey. With extensive experience, they offer expertise in navigating complex FDA requirements.
Additional information
### **Additional information**
- **Type:** independent
- **Company:** Sharlin Consulting
- **Years of experience:** 25
- **510(k)s submitted (self-reported):** 75
- **Regions served:** EU
- **Client types:** sme
- **Location:** EU (Washington)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** This consultant's value cannot be determined without further information from the website. The absence of an about section, services section, and LinkedIn profile limits the ability to assess their expertise and strengths.
- **Unique value:** Insufficient data to determine unique value proposition.
- **Ideal projects:** Without more information, it's impossible to define the ideal client or project for this consultant.
- **Confidence score:** 10/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, de-novo, pre-submission
- **Specialties:** regulatory strategy, risk management, quality system implementation
- **Device panels:** cardiovascular, neurology, orthopedic, gastroenterology, urology
- **Regulatory pathways:** 510k, pre-submission, de_novo, pma
- **Type:** independent
- **Company:** Sharlin Consulting
- **Years of experience:** 25
- **510(k)s submitted (self-reported):** 75
- **Regions served:** EU
- **Client types:** sme
- **Location:** EU (Washington)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** This consultant's value cannot be determined without further information from the website. The absence of an about section, services section, and LinkedIn profile limits the ability to assess their expertise and strengths.
- **Unique value:** Insufficient data to determine unique value proposition.
- **Ideal projects:** Without more information, it's impossible to define the ideal client or project for this consultant.
- **Confidence score:** 10/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, de-novo, pre-submission
- **Specialties:** regulatory strategy, risk management, quality system implementation
- **Device panels:** cardiovascular, neurology, orthopedic, gastroenterology, urology
- **Regulatory pathways:** 510k, pre-submission, de_novo, pma
Key Highlights
- This consultant's value cannot be determined without further information from the website. The absence of an about section, services section, and LinkedIn profile limits the ability to assess their expertise and strengths.
- Insufficient data to determine unique value proposition.
Certifications & Trust Signals
- 25 years experience
- 75 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- Without more information, it's impossible to define the ideal client or project for this consultant.
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:
cardiovascular, neurology, orthopedic, gastroenterology, urology
Accepting New Clients:
Yes
