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CRO SERVICES
Regulatory Affairs Services
Ensure a clear pathway to global market access with DCN Dx’s Regulatory Affairs Services. Whether navigating FDA approvals, international regulatory frameworks, or compliance requirements, our team provides strategic guidance and practical solutions tailored for diagnostic devices.
Regulatory Approval
Starts Here
DCN Dx offers comprehensive regulatory services to support diagnostic device approvals. Our capabilities include regulatory strategy and submission support for FDA pathways such as 510(k), de novo, and PMA, along with IVDR/MDR and global compliance initiatives. We provide pre-submission consulting to support early FDA engagement, develop Breakthrough Device (BTD) and Safer Technologies (STeP) program applications, and assist with verification, validation, and clinical trial planning. Our team also conducts QMS audits to meet FDA, ISO 13485, oversees post-market surveillance activities, performs risk assessment and regulatory pathway optimization, and delivers customized compliance solutions tailored to diagnostic devices.
Regulatory Strategy
Global Market Strategy
01
We guide clients through U.S. (FDA), European (IVDR/MDR), Canadian, Australian, Brazilian, Japanese, South Korean, and other international regulatory requirements.
Regulatory Classification and Pathway Determination
02
We help determine the appropriate regulatory classification and strategy, including pathways such as 510(k), de novo, PMA, IVDR, and others.
Verification and Validation Requirements
03
Our services include planning for electrical safety, biocompatibility, cybersecurity, software validation, labeling, shelf-life studies, analytical testing, waiver flex studies, clinical evaluation, and usability and human factors testing.
Regulatory Authority Engagement
04
We provide strategic preparation for communications with FDA and other global regulatory bodies, ensuring regulatory expectations are met throughout the process.
FDA Pre-Submission & Regulatory Consultation
DCN Dx enhances regulatory readiness by guiding clients through the FDA pre-submission process. We help assess whether a pre-submission meeting is beneficial, prepare key questions and supporting documentation to guide FDA feedback, and facilitate clear regulatory communication. Our team leads pre-submission meetings, summarizes key discussions, and ensures meeting minutes align with FDA expectations, streamlining the overall submission process.
Accelerated FDA
Review Pathways
We assess whether your diagnostic device qualifies for accelerated FDA programs designed to expedite market entry.
01
We guide clients through U.S. (FDA), European (IVDR/MDR), Canadian, Australian, Brazilian, Japanese, South Korean, and other international regulatory requirements.
Preparation of Pre-Submission Requests
02
We organize necessary data, literature, and agreements to support successful pre-submission engagement for fast-track programs.
Application Submission and Agency Communication
03
Our team handles the submission process, responds to FDA inquiries, and ensures ongoing compliance with program requirements to maintain eligibility and approval momentum.
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Regulatory Submissions
We Support
.01
Investigational Device Exemption (IDE) Submission
We perform risk assessments to determine IDE exemption status and coordinate with clinical teams to develop complete submission packages, supporting clinical study initiation and regulatory compliance.
.02
De Novo Submission
For novel devices without an established predicate, we guide you through the more rigorous de novo process, including expanded clinical study requirements, comprehensive risk/benefit analysis, and the development of special regulatory controls.
.03
IVDR/MDR Compliance (EU Submissions)
Our team prepares technical documentation, coordinates with notified bodies, drafts clinical evaluation reports, and supports conformity assessment and post-market surveillance under the IVDR/MDR regulatory frameworks.
.04
510(k) Submission
DCN Dx confirms the availability of a predicate device and justifies substantial equivalence through clear documentation. We assist with verification and validation data, prepare 510(k) submission packages, manage electronic filings, and respond to FDA requests throughout the review process.
.05
Premarket Approval (PMA)
We support high-risk Class III devices, typically requiring large-scale clinical studies, modular submission strategies, pre-approval inspections, and detailed post-market reporting to ensure successful PMA approval.
Post-Market Compliance and Other Regulatory Services
Quality System Audits
We perform internal audits aligned with FDA and ISO 13485 requirements to ensure ongoing compliance.
Design History File (DHF) Consulting
Our experts review and optimize DHFs to ensure alignment with regulatory expectations and support efficient product lifecycle management.
Labeling Reviews and Gap Assessments
We conduct thorough assessments of labeling, documentation, and regulatory gaps to support corrective action planning and compliance maintenance.
Complaint, Adverse Event, and Recall Consulting
DCN Dx helps you build compliant systems for complaint handling, adverse event reporting, and product recall execution to meet regulatory requirements.
Global Privacy Law Compliance (HIPAA and GDPR)
Our team advises on compliance strategies for global privacy regulations, including HIPAA for U.S. markets and GDPR for EU markets.
Meet with our team
Our Regulatory Affairs team is here to make your project a success.
Regulatory Insights
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