Practical Excel templates for QMSR implementation, FDA inspection readiness, design controls, SaMD and IVD teams. Each one pairs with an in-depth companion guide.
14 templates · Each spreadsheet carries the Cahir MedTech logo and © Cahir AI LLC.
Each workbook opens with a Universal Baseline of the requirements every device team needs, then adds five device-category overlay tabs — SaMD, IVD, Implantable, Capital Equipment and Consumable — so you work only with what fits your device and your activities.
Alongside those tabs, a Sources and Applicability tab lists the FDA guidance, standards and regulations behind every item and when each one applies to you, so anything you carry into a submission traces back to its source. All of it is free with a quick business sign-up.
Free sign-upReadiness assessmentKnow exactly where you stand before FDA does.
Free sign-upRequirements mappingClause-by-clause bridge from certificate to compliance.
Free sign-upInspection rehearsalRehearse the inspection like it's the real one.
Free sign-upLifecycle traceabilityConnect user needs to evidence across the device lifecycle.
Free sign-upResponse coordinationTurn observations into an evidence-backed response plan.
Instant download. Each workbook carries locked Cahir MedTech branding and © Cahir AI LLC.
14 of 14 templates
QMSR Implementation
Track readiness across every QMSR requirement.
Clause-by-clause tracker with owners, evidence status and due dates for inspection-ready implementation.
QMSR Implementation
Find the gaps between ISO 13485 and FDA QMSR.
Side-by-side gap log covering FDA-specific additions, records and labeling controls.
QMSR Implementation
Plan the QMSR transition in three 30-day phases.
Phased task plan with milestones, owners and acceptance evidence for each step.
FDA Inspection Readiness
Organize evidence across the six CP 7382.850 QMS areas.
Index of records, locations and owners so teams can retrieve evidence quickly during inspection.
FDA Inspection Readiness
Map old QSIT preparation to the new inspection approach.
Crosswalk of QSIT subsystems to CP 7382.850 areas with preparation actions.
FDA Inspection Readiness
Close common Form 483 gaps before inspection.
Register of likely observation areas, gap status, remediation and supporting evidence.
Design Controls and Closed-Loop Quality
Plan design control evidence from inputs to review.
Traceability planner linking inputs, outputs, verification, validation and design reviews.
Design Controls and Closed-Loop Quality
Confirm a design is ready for controlled production.
Checklist for specifications, process validation, supplier readiness and pilot-lot evidence.
Design Controls and Closed-Loop Quality
Connect complaints, MDR decisions, CAPA and risk files.
One evidence chain from complaint intake through reportability, CAPA effectiveness and risk updates.
SaMD, Imaging AI and Digital Health
Document design controls and changes for AI/ML devices.
Register for model versions, software validation, change assessments and supporting evidence.
SaMD, Imaging AI and Digital Health
Trace radiology AI from dataset to clinical validation.
Matrix covering dataset sourcing, reference standards, subgroup performance and clinical evidence.
SaMD, Imaging AI and Digital Health
Check SaMD release readiness for digital pathology software.
Release checklist for lifecycle, validation, cybersecurity and change control evidence.
SaMD, Imaging AI and Digital Health
Plan software changes with evidence matched to risk.
Planner for change tiers, required evidence, cross-functional review and PCCP fit.
IVD
Prepare IVD lot traceability and supplier evidence.
Register for inspection readiness, lot traceability, supplier controls and reagent evidence.
Build plans and checklists online with our step-by-step guides.
