Emergo by UL
FDA 510(k), De Novo, PMA Consulting for Medical Devices by Emergo by UL
Emergo by UL is a leading global QA/RA consulting firm dedicated to helping medical device companies successfully navigate complex FDA regulatory pathways. With a strong specialization in FDA 510(k) submissions, they have a proven track record of hundreds of cleared 510(k)s. Their comprehensive services extend to De Novo applications and PMAs, supporting clients in the US, EU, and globally. Leveraging their extensive experience, Emergo by UL empowers medical device manufacturers to achieve regulatory compliance and market access.
About
Emergo by UL is a leading global QA/RA consulting firm dedicated to helping medical device companies successfully navigate complex FDA regulatory pathways. With a strong specialization in FDA 510(k) submissions, they have a proven track record of hundreds of cleared 510(k)s. Their comprehensive services extend to De Novo applications and PMAs, supporting clients in the US, EU, and globally. Leveraging their extensive experience, Emergo by UL empowers medical device manufacturers to achieve regulatory compliance and market access.
Additional information
### **Additional information**
- **Type:** firm
- **Company:** Emergo by UL
- **Years of experience:** 20
- **510(k)s submitted (self-reported):** 10
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Emergo by UL is a well-established regulatory consulting firm specializing in FDA 510(k) submissions. Their affiliation with UL suggests a focus on quality and safety, which could be valuable for clients seeking a thorough and reliable partner.
- **Unique value:** Emergo by UL provides FDA 510(k) consulting services backed by the reputation and resources of UL, a global leader in safety science.
- **Ideal projects:** The ideal client is a medical device company, particularly SMEs, seeking assistance with FDA 510(k) submissions. Companies that need guidance on navigating the regulatory landscape and ensuring compliance would benefit from their services.
- **Confidence score:** 75/100
- **Last analyzed:** Sun Dec 14 2025 01:05:47 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, pma, international
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** other, software-samd, ivd
- **Regulatory pathways:** 510k, de_novo, pma
- **Type:** firm
- **Company:** Emergo by UL
- **Years of experience:** 20
- **510(k)s submitted (self-reported):** 10
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Emergo by UL is a well-established regulatory consulting firm specializing in FDA 510(k) submissions. Their affiliation with UL suggests a focus on quality and safety, which could be valuable for clients seeking a thorough and reliable partner.
- **Unique value:** Emergo by UL provides FDA 510(k) consulting services backed by the reputation and resources of UL, a global leader in safety science.
- **Ideal projects:** The ideal client is a medical device company, particularly SMEs, seeking assistance with FDA 510(k) submissions. Companies that need guidance on navigating the regulatory landscape and ensuring compliance would benefit from their services.
- **Confidence score:** 75/100
- **Last analyzed:** Sun Dec 14 2025 01:05:47 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional, de-novo, pma, international
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** other, software-samd, ivd
- **Regulatory pathways:** 510k, de_novo, pma
Key Highlights
- Emergo by UL is a well-established regulatory consulting firm specializing in FDA 510(k) submissions. Their affiliation with UL suggests a focus on quality and safety, which could be valuable for clients seeking a thorough and reliable partner.
- Emergo by UL provides FDA 510(k) consulting services backed by the reputation and resources of UL, a global leader in safety science.
Certifications & Trust Signals
- 20 years experience
- 10 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The ideal client is a medical device company, particularly SMEs, seeking assistance with FDA 510(k) submissions. Companies that need guidance on navigating the regulatory landscape and ensuring compliance would benefit from their services.
HQ:
United States
Languages:
English
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device, IVD, Combination product
Supports Predicate Research:
Yes
Years Experience:
20
Num510k Submitted:
10
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Engagement Models:
Subscription
Accepting New Clients:
No
Supports Estar:
No
Supports Rta Remediation:
No
Supports Labeling Review:
No
Provides Submission Project Management:
Yes
