For MedTech founders, innovators & executives
Turn your next milestone into an evidence-backed plan.
Know what to prepare, who owns it and which evidence is still missing. Practical workbooks for development, FDA conversations, quality readiness and commercial adoption—without starting from a blank spreadsheet.
Free work-email resources · Paid kits sold individually · One-time USD pricing
11 free workbooks
Plus individual templates in the catalog
6 paid execution kits
From response planning to hospital adoption
One shared plan
Owners, evidence references and next actions
Built for the decisions ahead
Cahir MedTech toolkits are Excel-based planning and evidence-coordination resources. They give your team a structured starting point, not a completed submission or a promise of approval.
What should we formalize before the next study?
Map user needs, design evidence, risk controls and transfer readiness. Surface gaps while plans are still changeable.
Start free: R&D to Design Controls Transition Checklist
What needs to be ready for a reviewer?
Organize FDA questions, planned AI changes, inspection evidence and response commitments into reviewable workstreams.
Go deeper: Q-Sub Master Pack or AI/ML PCCP Suite
What evidence will a buyer or payer need?
Connect launch readiness with clinical value, hospital budget impact and coding, coverage and payment planning.
Go deeper: Hospital VAC Dossier or Reimbursement Roadmap
Paid execution kits
Use free tools to identify the gap. Invest in a deeper workbook and companion guide when your team needs a coordinated preparation workflow. Each purchase is separate; applicable taxes may apply.
Frame decision-ready FDA questions, organize your briefing and track feedback through protocol planning.
Define proposed model modifications, update methods, validation criteria and monitoring responsibilities.
Changes remain subject to the scope and protocol of an FDA-authorized PCCP; not every update qualifies.
Coordinate issued observations, product-impact review, CAPA evidence and response commitments.
Rehearse record retrieval, assign subject-matter experts and identify evidence gaps before inspection.
Build a hospital-facing evidence dossier with budget-impact assumptions and stakeholder responses.
Separate coding, coverage and payment decisions and organize the evidence and milestones for each.
Start before you buy
New to development planning? Start with the free transition checklist. Preparing an IVD pathway or AI evidence plan? Try the free Point-of-Care IVD De Novo & CLIA Waiver Planner or AI/ML Diagnostics PCCP & Evidence Planner.
For commercial teams, the free launch-readiness, postmarket-surveillance and dual-intent-evidence workbooks provide practical starting points.
Find free work-email resourcesWatch the open four-minute question-matrix walkthrough. Its illustrative examples show how to pair a focused FDA question with a proposed approach and supporting rationale—not an actual FDA meeting or an FDA endorsement.
No registration to watch. An optional work-email form offers a free one-page summary PDF.
Play free walkthroughFor founders, a structured workbook makes the next evidence question concrete. For executives, the company workspace makes checklist progress, ownership and unresolved actions easier to review together.
Select the kit for your current development, review or adoption decision.
Assign actions, document assumptions and review gaps with qualified leads.
Use shared checklist progress, notes, due dates and evidence references in your workspace.
Downloaded workbooks do not automatically synchronize with the workspace. Maintain approved records in your controlled QMS. Toolkits are separate from MedTech Compass intelligence and MedTech Copilot documentation services.
Cahir MedTech resources are planning aids, not regulatory, legal or reimbursement advice. Validate current source requirements and device-specific applicability before relying on a plan.
