MedQAIR
MedQAIR Services B.V.
FDA 510(k) Regulatory Consulting Firm
MedQAIR is a consulting firm specializing in FDA 510(k) regulatory consulting for international medical device manufacturers. Their services include 510(k) submissions for Class I and Class II general hospital devices, helping clients achieve successful market clearances.
Buyer Snapshot
Best for
- Manufacturers of medical devices seeking regulatory guidance.
- Companies developing AI-enabled medical devices.
- IVD manufacturers needing compliance support.
How engagement typically works
- Consultative approach to regulatory strategy.
- Documentation preparation for submissions.
- Post-market compliance support.
Typical deliverables
- Technical documentation for submissions.
- Regulatory strategy plans.
- Compliance guidance for AI and medical devices.
Good to know
- Best when clients require assistance navigating complex regulatory pathways for medical and AI devices.
HQ:
Amsterdam, United States
Languages:
English
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Medical Device Reimbursement, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Labeling Review for Submission (510(k)/De Novo/PMA), 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, SaMD
Years Experience:
12
Num510k Submitted:
10
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Technology Types:
Artificial Intelligence, Software as a Medical Device
Engagement Models:
Interim Support
Accepting New Clients:
Yes
Supports Estar:
Yes
Supports Rta Remediation:
No
Supports Predicate Research:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
