Describing the purpose of a health product
A blank worksheet and worked example for defining a health product's configuration, users, setting, input, output and intended action.
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A measurement evidence record for wearable products
A blank record and worked example for a wearable signal, configuration, comparison method, users, conditions, result and change trigger.
Read the resourceDocumenting quality responsibilities across a supply chain
A responsibility matrix, change example and handover checklist for manufacturers, suppliers, laboratories and service providers.
Read the resourceReading a testing performance report in context
A worked report extract and blank review note for configuration, comparison, denominators, missing results, uncertainty and limits.
Read the resourceConnecting product statements to supporting evidence
A blank evidence map and worked examples for wearable, nutrition and connected-health product statements.
Read the resourceA connected-health data handover worksheet
A field dictionary, example records and failure-state matrix for connected-health data handovers.
Read the resourceReporting a manufacturing environmental case study
A blank case-study record and worked calculation for baseline, boundary, production context, result and limitations.
Read the resourceMembership must be described accurately
IAHPM's position, with examples, on separating organisational membership from product approval, certification and endorsement claims.
Read the resourceWhere health-product manufacturing interfaces meet
A qualitative, source-led comparison of product identity, evidence, responsibility and user-facing information across health-product sectors.
Read the resourceNutrition product information: from ingredient to finished product
A worksheet and worked change example linking ingredient specifications, formulation, finished-product records and product information.
Read the resourceReviewing information for a home-monitoring device
A use-journey checklist and worked software-change example for home-monitoring set-up, measurement, results, support and maintenance.
Read the resourceRecording fit, use and maintenance for an assistive product
A blank record and worked setting-change example for assistive-product function, fit, configuration, use, maintenance and support.
Read the resourceUnited States: official sources for product purpose and general wellness
A dated reading route to current FDA sources for medical-device status, general-wellness products and healthy-lifestyle software functions.
Read the resourceEuropean Union: official sources for intended purpose and medical-device frameworks
A dated reading route to the EU MDR, IVDR and current European Commission guidance by product and subject.
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Choose by task
- Describe a product: start with the product-purpose record.
- Review evidence: use the wearable record, testing-report review or statement–evidence map.
- Clarify responsibility: use the supply-chain, nutrition or assistive-product record.
- Check a data interface: use the connected-health handover worksheet.
- Read a market source: use the United States or European Union guide.
- Report a manufacturing change: use the environmental case-study record.
Publication types
A practice resource provides a worksheet, example or repeatable method. An industry analysis states its question, sources, observations and limits. A policy position is an approved IAHPM view and is clearly labelled. Official external sources retain the issuing authority's authorship.
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