Back to customer servicesMedical device clinical and regulatory teams

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

A product family has an evidence baseline. New studies, corrections or design changes keep appearing, and the team repeatedly searches through old materials.

How does this scope address your concerns?

An update could miss version differences; an annual service could also be mistaken for worldwide coverage or all post-market responsibilities.

When this scope fits

For clinical or registration teams with an evaluation baseline that want to maintain one product family in one market.

When the scope needs adjusting

Literature updates are not complete post-market clinical follow-up or statutory adverse-event monitoring. New indications, markets, major design changes and new clinical studies need separate scopes.

REAL SOURCES · ILLUSTRATIVE REQUEST · DOWNLOADABLE SAMPLE

After an implant change, trace which evidence needs review

Download sample packZIP

Evidence trace for one change

01
Baseline
Product family v1, evaluation report and risk-record versions
02
Change
Assumed surface-processing change; technical materials needed
03
Difference assessment
Check contact materials, release characteristics and clinical use
04
Quarterly update
Record affected claims, reusable sources, gaps and owners

Workflow informed by MDCG 2020-7. The package maintains literature and differences, not manufacturer PMCF execution or regulatory responsibility.

Check	Finding / sample content	Use
Reuse of evidence	Prior sources are neither all discarded nor automatically reused	Document relevance to the change item by item
No literature change	A product change can still trigger a difference review	Report product changes and literature changes separately

SOURCES USED IN THIS EXAMPLE

Prepared 5 Oct 2026 · Selected references, not an exhaustive systematic search

Scope & acceptance

Work covered by the quote

Illustrative scope: 1 product family, 1 market and 5 agreed questions; quarterly scans and 4 update reports, up to 80 new full texts annually and 2 in-scope difference assessments.

Pilot reference: CNY 200,000–1,000,000+ per year. Fictional budget: CNY 200,000—scans and maintenance CNY 120,000; professional reports and difference assessments CNY 80,000. Quarterly payments: CNY 50,000 each. New markets, indications, major changes and clinical studies are agreed separately.

Acceptance criteria

Evidence versions clearly correspond to product versions. The scope, original sources and unresolved questions of each update can be checked.

Checking the evidence

Allowances follow illustrative scopes in the current pilot proposal. Customer situations, walkthroughs and budgets are fictional examples, not actual orders, product findings or validated savings.
The existing evaluation baseline, product versions and change records, plus new or corrected quarterly literature; each update links to original sources.

Workflow and inputs

From inputs to delivery

Explore the workflow and deliverable structure. This preview does not run searches, read real records or produce medical findings.

01 / WORKFLOW PREVIEW

Define the task

Illustrative request: an orthopaedic-device company wants to maintain 5 agreed questions for one product family without restarting every quarter.

Methods, sources and professional responsibilities

THE BASIS FOR THIS SCOPE

Why this approach? Inspect the basis.

Check the match between product, population, use conditions and outcomes before defining a supported claim.

OFFICIAL GUIDANCE

FTC · Health Products

Federal Trade Commission · US

Does the research match the product claim?

Scientific support for health-product claims should match the product and claim, rather than merely a similar ingredient.

Scope & access conditions

This is US guidance. Other markets require separate assessment; it is not an approval or compliance conclusion.

Open official source

PUBLIC DATABASE

ClinicalTrials.gov

NLM / NIH

Check studies and reported results

Review study objectives, eligibility, locations, status and reported results, then identify questions for the clinical team.

Scope & access conditions

Sponsors or investigators submit the records. A listing is not government approval of safety or effectiveness, or a determination that you should participate.

Read the official description

Open official source

METHOD REFERENCE

GRADE · Cochrane Handbook

Cochrane · Chapter 14

Show effect size and confidence separately

Present important outcomes, relative and absolute effects, available data and certainty, with reasons for downgrading.

Scope & access conditions

GRADE evaluates a body of evidence for a particular outcome. Database inclusion or one study does not automatically establish high certainty.

Open official source

These references support problem definition and evidence appraisal. Your conclusions still require project-specific sources and professional review.

The value of this commissionEOS assesses reuse and gaps for version changes and agreed claims, retaining adverse and uncertain findings.

Post-market device evidence updatesCompare alternatives and value

After a product change, does the old evidence still apply?

What to assess	ICON	Evidence OS · Commissioned scope
Service focus	ICON provides lifecycle HEOR and evidence services.	EOS assesses reuse and gaps for version changes and agreed claims, retaining adverse and uncertain findings.
When to choose	Global trials, real-world execution and submissions need full specialist capacity.	Example: one product family and market, five questions, four reports, up to 80 new full texts and two change assessments.

What the fee pays for: Planning reference: CNY 200,000–1,000,000+ annually; new purposes, markets and trials are separate projects.
Value beyond this task: Transfer old/new-version evidence maps as the baseline for later iterations.
How to assess value: Measure version-claim coverage, reassessment rework and repeated literature-check time.

Check whether vigilance and PMCF are included; do not imply completion without scope and qualifications.

CHECK THE OFFICIAL SERVICE SCOPEICON · Health Economics and Outcomes Research

Reuse and updates after delivery

Existing materials retain a verifiable link between evidence versions and product versions. Review discussions can begin with changes rather than reorganising the entire baseline.

Agree reuse rights, retention and export periods, and future update fees when scoping.

Questions before commissioning

Will there be a report if no new literature appears?

The scan scope and absence of detected changes are recorded. No evidence change is not presented as a new product-benefit finding.

Does this include post-market clinical follow-up and adverse-event monitoring?

It does not include a complete follow-up or statutory monitoring system. Responsibilities and executing organisations need separate arrangements; literature updates cannot replace them.

Can you connect directly to our enterprise system now?

The page presents a maintenance proposal for discussion. Interfaces, permissions, staffing, contracts and delivery methods require individual confirmation; connectivity is not claimed.

Define the delivery for your actual question.

Add your goal, available inputs and timing. Agree scope, review responsibilities and a quote before commissioning.

Request scope & quote

Explore other situations

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