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Submission requirements

See what a reviewer will ask you for.

Pick your product category and target region. This is the evidence structure DSRV works from, section by section, with the regulation or guidance behind every line. No account, no upload, no readiness grade.

Product category

Submission region

Only the regions listed above have a published checklist for medical devices today. Ask DSRV if you need another region.

Medical devices · United States (FDA)

7 sections · 22 evidence items

Citations are regulatory anchors for orientation, not an exhaustive or binding checklist. DSRV's reviewer confirms applicability to your specific product and submission type.

  1. Section 01

    Device Overview & Classification

    • FDA21 CFR 807 — premarket notification; device classification

    • Device description and intended use

    • Classification / regulatory pathway rationale

    • Predicate device comparison (substantial equivalence)

  2. Section 02

    Design Controls

    • FDA QSR21 CFR 820.30 — design controls

    • Design inputs / outputs

    • Design verification evidence

    • Design validation evidence

    • Design history file references

  3. Section 03

    Risk Management

    • ISOISO 14971 — application of risk management to medical devices

    • Risk management file / analysis

    • Risk-benefit rationale

  4. Section 04

    Performance & Bench Testing

    • FDARecognized consensus standards; device-specific guidance

    • Bench / performance test reports

    • Biocompatibility evaluation (ISO 10993 series)

    • Sterilization validation (if applicable)

    • Shelf life / packaging integrity testing

  5. Section 05

    Software / Cybersecurity (if applicable)

    • FDAFDA premarket software & cybersecurity guidance; IEC 62304

    • Software documentation level + lifecycle evidence

    • Cybersecurity risk documentation

  6. Section 06

    Labeling

    • FDA21 CFR 801 — device labeling

    • Label copy

    • Instructions for use

  7. Section 07

    Submission Readiness Review

    • DSRVDSRV submission-readiness review gate

    • Completeness checklist

    • Missing items

    • Reviewer comments

    • Client action items

    • Readiness status

What happens next

Nothing here needs a document from you

This list is the starting structure, not a verdict on your programme. Evidence only moves into a private, engagement-scoped workspace after confidentiality scope is agreed, and a DSRV reviewer confirms which items actually apply to your product.