01 Choose the record Select the worksheet that matches your task.02 Link the evidence Use original sources, document identifiers and actual dates.03 Save and export Keep an editable copy for your controlled internal workflow.
Choose your worksheet. WorksheetDevice & intended-use profile Requirement-to-evidence record Standards & test evidence Supplier & incoming acceptance Change-impact assessment Safety-alert impact record Asset & maintenance review Clinical / performance follow-up plan Device & intended-use profile Create a common starting point for the regulatory, clinical and engineering teams.
Requirement-to-evidence record Document one requirement, its applicability and the evidence used to address it.
Requirement / clauseExact identifier; distinguish law, guidance and standard. Original source & versionURL, document title, date and status. Applicability rationaleApplicable, not applicable or unresolved, with reason. Device / configurationLink to the exact product profile. Evidence identifierReport, drawing, protocol or other controlled record. Review finding & limitationsState what the evidence supports and does not resolve. Open gap / corrective actionAction, responsible role and due date. Review & approval recordRecord reviewer role, decision and actual review date.
Standards & test evidence Keep editions, recognition limits and laboratory evidence together.
Standard / part / editionInclude amendments and relevant clauses. Device & applicable scopeState why this standard applies. Regulatory recognitionOriginal register, scope, restrictions and checked date. Laboratory & accreditation scopeRecord applicable current credentials. Test article / configurationModel, version, manufacturing and sterilization status. Protocol & acceptance criteriaIdentifiers and justified deviations. Report / result / limitationsRecord the controlled report and unresolved items. Owner & review dateWho reviews the record and when?
Supplier & incoming acceptance Link purchasing decisions to evidence, delivery and service requirements.
Item / model / configurationInclude accessories and consumables in scope. Supplier & responsible rolesManufacturer, authorised representative or distributor, as relevant. Product and establishment evidenceRecord applicable authorizations and verification links. Technical and clinical needLink specifications to the intended service. Storage / transport / shelf lifeRecord specified conditions and evidence requirements. Installation / training / serviceAvailability of trained staff, spares and consumables. Acceptance criteria & actual evidenceCommissioning, documents, identity and quantity checks. Gaps / disposition / ownerDocument the decision, follow-up and review date.
Change-impact assessment Record a proposed design, software, process or supplier change and its evidence impact.
Change & reasonCompare the current and proposed configurations. Products / versions / markets affectedRecord scope precisely. Safety and performance impactIdentify affected hazards, claims and users. Evidence to reassessBiological, usability, software, clinical or other evidence. Verification / validation planIdentify protocols, criteria and responsible roles. Regulatory assessmentLink the jurisdiction-specific rule; record unresolved questions. Implementation decisionApproval, dependencies, date and rollback arrangements. Post-change monitoringDefine evidence to check and the next review.
Safety-alert impact record Translate an official alert into traceable local follow-up without changing its scope.
Official alert & original dateOriginal URL, authority and alert identifier. Affected model / lot / serial / versionCopy identifiers accurately from the original. Inventory / locations in scopeRecord reconciliation results, without patient identifiers. Required official actionKeep the regulator’s distinctions and conditions. Local impact assessmentRecord what is confirmed and what needs clarification. Owner / due date / follow-upUse the actual official deadline if one exists. Action evidenceDocument identifiers and reconciliation results. Review & closure rationaleRecord decision, reviewer role and actual date.
Asset & maintenance review Bring identity, location, service history and lifecycle decisions into one worksheet.
Asset / serial / modelUse a unique identifier for the physical unit. Location & responsible serviceDepartment, use setting and responsible role. Manufacturer instructionsReference the current device-specific service documentation. Service history & outstanding issuesDocument identifiers, findings and actual dates. Next service / reviewUse the applicable programme and authorized technical assessment. Spares / skills / service supportIdentify support dependencies and shortages. Service status & decisionAvailable, under review or removed from service, with reason. End-of-life planLink the approved disposition and retained records.
Clinical / performance follow-up plan Organise unanswered questions, evidence sources and review decisions.
Device / claim / populationState the exact version and intended use. Unanswered evidence questionWhat uncertainty is the follow-up intended to address? Method & justificationLink the relevant clinical or performance approach. Outcomes & assessment criteriaPredefine the measurements and interpretation approach. Evidence sources & identifiersStudies, literature, service data or safety sources. Bias, limitations & missing informationRecord applicability and uncertainty. Ethics / regulatory / data governanceIdentify required reviews; do not enter patient information here. Owner / milestones / decisionLink actual review records and resulting actions.
These original Office worksheets organise review work. They are not regulator forms and do not determine compliance. Use your applicable requirements, controlled procedures and authorised review process.
Product-specific evidence checklists ↗ Editorial review: 3 October 2026. Source publication dates and versions remain those of the original publishers.