Medical device clinical and regulatory teams

Connect product features to the evidence needed for clinical claims.

Material, structural, and manufacturing advantages must be assessed separately from human clinical evidence. Define evaluation work packages by product, intended use, and target market.

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Illustrative scene: a health-product team reviewing products and documentation — Illustrative scene

Service usersClinical, regulatory, R&D, quality, and medical teamsCommissioning partyThe device registrant, manufacturer, or its authorized commissioning organization

Choose the deliverable you need

Inspect the value and deliverables, then agree scope, review and fees.

01 · FOCUSED

Device version & evidence check

Does research on similar technologies fit this product version?

Core valueSeparate related-technology evidence from this device version.

What you receiveCheck intended use, population, version and study differences.

Intended-use and product-version register
Study differences and source table
Evidence-gap list

PDF and CSV; define the intended purpose.

How fees workQuoted by device version, intended use and market

Appraise scope after agreeing inputs; subsequent evaluation is a separate package.

Scope limits

Excludes guaranteed equivalence, testing and registration agency work.

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02 · DEDICATED

Clinical evidence appraisal package

Clinical evaluation needs a consistent, traceable evidence synthesis.

Core valueSeparate performance, clinical outcomes and transfer assumptions.

What you receiveAppraise evidence quality, effects and risks around intended use and outcomes.

Search, screening and source index
Effects, risks and applicability matrix
Appraisal report and methods appendix

Report and tables; agree review roles and formal intended use.

How fees workQuoted by appraisal module, source volume and professional review

Accept and pay for scope, evidence draft and final report by milestones.

Scope limits

Excludes required trials and approval guarantees.

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03 · CUSTOM

Lifecycle evidence maintenance

Product updates make earlier evidence difficult to map to the new version.

Core valueKeep track of usable evidence after product changes.

What you receiveMaintain version-to-evidence mapping and prioritise further research.

Version, intended-use and evidence baseline
Incremental appraisal and evidence-development plan
Staged review and update dossier

Accept by versions and milestones; regulatory judgments remain with the responsible parties.

How fees workBaseline and version maintenance quoted separately

Pay by agreed periods and versions; approve changes for new uses, markets or out-of-scope versions.

Scope limits

Excludes full post-market follow-up and statutory event monitoring.

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Explore your business context: Health brands Pharma Medical devices CRO

Amounts are proposed references or examples. Formal quotes depend on inputs, questions, professional review and acceptance scope. Agree updates separately; the same work is not charged twice.

What inputs are needed?

Product and market: Intended use, product version, target market, and evaluation stage
What needs to be demonstrated?: Clinical claims, comparator products, endpoints, and follow-up
Existing evidence: Technical, nonclinical, and human clinical records, with permissions for use

More situations

Situations and deliverables

Medical device clinical and regulatory teams

Technical performance is strong. How far can your clinical claim go?

Receive a claim-to-evidence table, a product-difference matrix, a literature source package and next-step evidence questions.

CNY 50,000–200,000 per module; comprehensive programmes: CNY 200,000–800,000+See the deliverable

Medical device clinical and regulatory teams

Your evaluation baseline is ready, but new evidence and product changes are not kept aligned.

Maintain evaluation materials quarterly, record evidence and product-difference changes, and explain their effect on existing claims and outstanding evidence needs.

CNY 200,000–1,000,000+ per yearSee the deliverable

NEXT STEP

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Agree the scope, deliverables and review responsibilities before commissioning work.

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