Lexology
Law Business Research
Lexology – FDA 510(k) & Regulatory Consulting
Lexology is a specialized FDA regulatory consultant with 7 years of experience, focusing on providing expert guidance for medical device companies. They excel in navigating complex regulatory pathways, including 510(k) submissions, pre-submission meetings, IDE, and IND applications. Their expertise extends to critical areas such as regulatory submissions, risk management, usability engineering, clinical evaluation reports, and technical documentation.
Buyer Snapshot
Best for
- Identifying leading legal practitioners and firms
- Accessing practical legal resources and research
How engagement typically works
- Contribution-based research process
- Nomination and submission of work highlights
Typical deliverables
- Legal research reports
- Lists of international legal leaders
- Regulatory intelligence
Good to know
- Best when seeking to understand market leaders and research trends in legal services.
HQ:
London, US
Languages:
English
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Predicate Research & Substantial Equivalence Strategy, 510(k) Strategy & Authoring, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k)
Device Types Supported:
Medical device
Years Experience:
7
Num510k Submitted:
3
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general-hospital
Accepting New Clients:
Yes
Supports Predicate Research:
Yes
Provides Submission Project Management:
Yes
Supports Estar:
No
Supports Rta Remediation:
No
Supports Labeling Review:
Yes
