Regulatory Compliance Associates
Regulatory Compliance Associates – FDA Regulatory Consulting for Medical Devices
Regulatory Compliance Associates is a dedicated FDA regulatory consulting firm specializing in medical device companies. Their expertise encompasses comprehensive regulatory pathway assessment, robust ISO 13485 Quality Management System (QMS) consulting, and thorough ISO 14971 risk management.
Buyer Snapshot
Best for
- Medical device manufacturers seeking FDA clearance/approval.
- Pharmaceutical companies navigating product lifecycle regulations.
- Companies requiring support with EU MDR compliance.
How engagement typically works
- Consultative guidance throughout the regulatory process.
- Project-based support for specific submission needs.
- Staff augmentation for regulatory affairs.
Typical deliverables
- Regulatory strategy and submission support.
- Product lifecycle management guidance.
- Compliance and remediation plans.
- Post-approval support processes.
Good to know
- Best when requiring expert navigation of FDA and EU regulatory frameworks for medical devices and pharmaceuticals.
HQ:
EU
Languages:
English
Timezones:
UTC, EST
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, Traditional 510(k) Support, Special 510(k) Support, Abbreviated 510(k) Support, 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), PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device, SaMD
Supports Rta Remediation:
No
Supports Predicate Research:
No
Years Experience:
25
Num510k Submitted:
75
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general hospital, cardiovascular, neurology, orthopedic, gastroenterology
Accepting New Clients:
Yes
Supports Estar:
No
Supports Labeling Review:
No
Provides Submission Project Management:
Yes
