Intertek
★★★★★
3.8
/ 5
•
12 reviews
Expert FDA 510(k) Regulatory Consulting Firm | Global Testing & Training
Intertek is a distinguished full-service CRO and global testing organization with extensive expertise in FDA 510(k) regulatory consulting. They specialize in providing comprehensive 510(k) consulting and training services, empowering medical device companies to successfully navigate complex FDA regulatory pathways and achieve timely clearances. Intertek serves clients across the US, EU, and globally, offering dedicated support for regulatory success.
Buyer Snapshot
Best for
- Medical device manufacturers seeking FDA 510(k) clearance
- Companies needing expert regulatory guidance for US market entry
How engagement typically works
- Consulting on regulatory strategy
- Submission preparation and support
Typical deliverables
- FDA 510(k) submission strategy
- Regulatory consulting reports
- Testing and training services
Good to know
- Best when requiring specialized FDA 510(k) expertise.
HQ:
London, United States
Languages:
English
Timezones:
UTC, GMT
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Predicate Research & Substantial Equivalence Strategy, 510(k) RTA Remediation / Refuse-to-Accept Fix, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k)
Device Types Supported:
Medical device, IVD, SaMD, Combination product
Supports Predicate Research:
Yes
Years Experience:
15
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general-hospital
Engagement Models:
fixed_fee
Accepting New Clients:
No
Supports Estar:
Yes
Supports Rta Remediation:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
