QMSAdvisor

Certification and Market Access

Submission Readiness (510(k), De Novo, PMA, Pre-Sub, 513(g))

A premarket submission is only as strong as the design and risk evidence behind it. We prepare that quality evidence, from a complete design history to a current risk file and traceable verification and validation, so your regulatory team builds the submission on solid ground.

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What You Receive

  1. 01Design History File Gap Review
  2. 02Requirements and Risk Traceability Matrix
  3. 03Risk File Review
  4. 04Pre-Submission Evidence Package
  5. 05Open Items List Before Filing

Every finding is reviewed and approved by a qualified QMS advisor before it reaches you.

What It Is

FDA's premarket pathways ask different questions. A 510(k) shows substantial equivalence to a legally marketed predicate device. De Novo classification is a route for novel devices of low to moderate risk with no predicate. A premarket approval (PMA) application, used for Class III devices, has to show reasonable assurance of safety and effectiveness, and FDA generally inspects the manufacturing site before approval. A 513(g) request asks FDA for information about a device's classification and the requirements that may apply, and a Pre-Submission under the Q-Submission program gets FDA feedback on a planned submission or study before you commit.

Each pathway draws on the same quality evidence. Design inputs and outputs, verification and validation results, the risk management file, usability and software documentation, and design reviews all come from your design controls. When these sit in scattered folders, with test reports that trace to old requirements or risk controls that were never verified, the submission team spends its time reconstructing history, and reviewer questions get harder to answer.

Our role is the quality evidence. We check the design history file for completeness, trace requirements through risk controls to verification and validation, and help prepare the evidence and questions for a Pre-Submission meeting. Regulatory strategy, such as pathway choice and predicate selection, is scoped case by case with your regulatory lead. Clearance, classification and approval are FDA decisions, and we don't promise any of them.

When You Need It

  • You're preparing a 510(k), De Novo or PMA and your design history file has never been reviewed end to end
  • Verification and validation reports don't trace cleanly to requirements and risk controls
  • FDA has asked for additional information and the answer is buried somewhere in the design records
  • You want a Pre-Submission meeting and need your questions and supporting evidence in order
  • Your device's classification is unclear and you're considering a 513(g) request
  • A PMA is planned and the manufacturing site has to be ready for a pre-approval inspection

What We Do

  1. 01

    Collect the Design Record

    You upload the design and development files you already have. The AI does a first pass that maps them against design control and risk management expectations, and an advisor reviews every result.

  2. 02

    Check Design History Completeness

    We check that design plans, inputs, outputs, reviews, verification, validation, transfer and changes are documented, approved and consistent with the device as it will be submitted.

  3. 03

    Trace Requirements Through Verification

    We build or check the trace from user needs and design inputs, through risk controls in the ISO 14971 file, to verification and validation evidence, and flag every broken link.

  4. 04

    Prepare for the Pre-Submission

    We help frame focused questions, assemble the supporting evidence and plan how FDA's feedback will be recorded and carried into design and testing decisions.

  5. 05

    Close Gaps Before Filing

    Findings go into an action plan with owners and due dates. Your team submits evidence, and an advisor accepts it or requests a revision.

  6. 06

    Connect to Inspection Readiness

    For a PMA, we link the submission evidence to pre-approval inspection preparation, so the site and the file tell the same story.

Deliverables

  • Design History File Gap Review

    Advisor-reviewed findings on missing, unapproved or inconsistent design records, with sources and owners.

  • Requirements and Risk Traceability Matrix

    User needs and design inputs traced through risk controls to verification and validation, with gaps marked.

  • Risk File Review

    Notes on whether hazards, risk controls and benefit-risk conclusions are current and consistent with test results.

  • Pre-Submission Evidence Package

    Organized supporting material and draft questions for your regulatory team to finalize.

  • Open Items List Before Filing

    What still needs to close, who owns it and the evidence each item needs.

How the Platform Helps

  • The Whole Design Record in One Library

    Upload design files, test reports and risk documents in their original formats. Each file is fingerprinted and duplicates are flagged, so you know which version is current.

  • Findings Tied to the Exact Document

    Every finding names the document and location it came from, which makes broken traceability quick to find and fix.

  • An Action Plan That Ends at Filing

    Owners, due dates and evidence requirements sorted by severity, aimed at your planned submission date.

  • Practice for a Pre-Approval Inspection

    For PMA projects, the FDA Inspection Simulator runs a practice inspection scoped by CP 7382.850 areas, including Design and Development, before the real one.

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Audits and Inspections It Prepares You For

Standards and Regulations in Scope

Questions About This Service

Do you write the 510(k) or PMA?

We prepare the quality evidence the submission depends on: the design history, the risk file and verification and validation traceability. Authoring and regulatory strategy, including pathway and predicate decisions, are scoped case by case with your regulatory lead after an assessment call.

Can you tell us whether FDA will clear our device?

No. Clearance, De Novo grants and PMA approval are FDA decisions. What we can do is help make the evidence you submit complete, consistent and traceable, so review questions are easier to answer.

What is a 513(g) request?

It's a written request asking FDA for information about how a device is classified and the regulatory requirements that may apply. It's useful when the classification or pathway is unclear. FDA's response is informational rather than a classification decision.

When should we request a Pre-Submission?

When you have specific questions where FDA feedback would change your plan, such as testing approach, clinical data needs or pathway, and enough design information for FDA to respond meaningfully. Ask focused questions and bring the evidence behind your proposed approach.

Does design control matter if FDA doesn't inspect before a 510(k)?

Yes. A 510(k) review doesn't typically include a pre-clearance inspection, but the QMSR applies to your device regardless. When FDA does inspect, investigators can compare your design records with what you submitted, so the two need to match.

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Discuss Submission Readiness With an Advisor

Tell us about your devices, your documents and your timeline, and an advisor will scope the work with you. Please don't send confidential documents yet: secure upload is set up after onboarding.

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