USFDA 510(k) and De Novo Submission
Accelerate Your FDA Clearance Journey with MedQCompliance
At MedQCompliance, we specialize in guiding medical device companies through the complete FDA 510(k) and De Novo submission process. Our end-to-end consulting services help streamline your regulatory pathway, reduce submission timelines, and ensure a smoother review experience – right through to clearance.
Our expert team supports you in:
Technical Documentation
Preparation aligned with the latest FDA guidance documents as per the applicable product classification and product code.
Verification & Validation Strategy
Planning and execution of clinical validation, compliance testing, human factors engineering, software verification, and cybersecurity assessments.
Regulatory Submissions
Crafting robust 510(k) or De Novo submissions tailored to your device and regulatory strategy.
FDA Interaction Support
Managing FDA queries, deficiency responses, and communication until successful clearance.
With MedQCompliance, you get a proactive, structured, and expert-driven approach to FDA submissions, helping you confidently navigate regulatory complexities and get your innovations to market faster.
Partner with us
To make your FDA submission journey efficient, predictable, and successful.
Frequently Asked Questions
Get quick answers to common questions about MedQ Compliance’s services and Medtech regulatory consulting.
You can connect with us through our website, LinkedIn, Google search, or referrals to schedule an initial consultation.
MedQ Compliance specializes in preparing a tailored regulatory strategy for your medical device solution, support in building technical documentation and completing regulatory submissions in global markets such as US FDA, EU MDR/ IVDR, CDSCO India, Singapore HSA, and other countries.
MedQ Compliance prioritizes confidentiality, implementing secure processes for information protection.
Timelines for regulatory approvals depend on multiple factors such as completeness of the technical dossier, meeting applicable requirements and timely communication with the regulatory bodies. MedQ Compliance optimizes all these key areas that ensure high efficiency and minimal timelines for regulatory clearances.