Qualio
Qualio – FDA 510(k) & Regulatory Consulting Expertise
Qualio offers expert guidance for medical device regulatory consulting firms, addressing key questions about their value and fees. They specialize in helping companies navigate the complexities of regulatory pathways.
About
Qualio offers expert guidance for medical device regulatory consulting firms, addressing key questions about their value and fees. They specialize in helping companies navigate the complexities of regulatory pathways.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 5
- **510(k)s submitted (self-reported):** 10
- **Location:** GB
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** This blog post discusses the cost of medical device regulatory consulting in 2020. It aims to help companies determine if the fees are worth the value provided.
- **Unique value:** Provides insights into the pricing of medical device regulatory consulting.
- **Ideal projects:** Medical device companies seeking to understand the costs associated with regulatory consulting services.
- **Confidence score:** 50/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, de-novo
- **Specialties:** risk management
- **Regulatory pathways:** 510k
- **Type:** independent
- **Years of experience:** 5
- **510(k)s submitted (self-reported):** 10
- **Location:** GB
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** This blog post discusses the cost of medical device regulatory consulting in 2020. It aims to help companies determine if the fees are worth the value provided.
- **Unique value:** Provides insights into the pricing of medical device regulatory consulting.
- **Ideal projects:** Medical device companies seeking to understand the costs associated with regulatory consulting services.
- **Confidence score:** 50/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, de-novo
- **Specialties:** risk management
- **Regulatory pathways:** 510k
Key Highlights
- This blog post discusses the cost of medical device regulatory consulting in 2020. It aims to help companies determine if the fees are worth the value provided.
- Provides insights into the pricing of medical device regulatory consulting.
Certifications & Trust Signals
- 5 years experience
- 10 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- Medical device companies seeking to understand the costs associated with regulatory consulting services.
HQ:
GB
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)
Device Types Supported:
Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
5
Num510k Submitted:
10
Accepting New Clients:
Yes
