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.
Buyer Snapshot
Best for
- Medical device companies seeking to simplify regulatory compliance.
- Organizations needing to automate RA/QA activities.
- Companies preparing for FDA submissions (510(k), De Novo, PMA).
How engagement typically works
- Consulting services for regulatory strategy and submissions.
- Software-as-a-Service (SaaS) for regulatory management.
- Access to digital tools for compliance monitoring and documentation.
Typical deliverables
- FDA 510(k), De Novo, PMA submission support.
- Regulatory compliance software (RAMS® modules).
- Market access strategy and support.
- Human factors research and design resources.
Good to know
- Best when seeking integrated solutions for regulatory affairs and quality assurance.
- Ideal for companies looking to leverage digital tools for efficiency.
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, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo
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
