Template

Medical Device Audit

100+

This Medical Device Audit checklist is a customizable template designed for healthcare facilities and medical device managers. It guides users through essential audit steps such as verifying device inventory, maintenance and servicing records, repair documentation, and staff training. Inspection findings can be captured with photos, notes, and digital signatures to ensure compliance and traceability. An ideal tool for internal audit teams, quality managers, and maintenance staff focused on device safety and operational integrity.

With Mitti you can

Digitize any process, procedure or policy

Eliminate mistakes made by paper-based processes

Create and share professional reports instantly

Confirm accountability and compliance with a digital log

With Mitti you can

Digitize any process, procedure or policy

Eliminate mistakes made by paper-based processes

Create and share professional reports instantly

Confirm accountability and compliance with a digital log

About author

Mitti

Mitti (by SafetyCulture) is the operations system for every site, shift and standard. Trusted by 80,000 organizations in 190 countries, Mitti publishes free checklists, SOP templates, audit checklists and toolbox talk topics that turn paper processes into a digital audit trail. Download one, put it to work on your next inspection or shift, and see why teams keep coming back for more.

Template

ISO 14971 Checklist

This checklist for medical device manufacturers is based on the scope, description, and guidelines of ISO 14971. This can be used for conducting risk management checks on medical devices. Repeat sections as necessary per medical device or part and use the guide questions to conduct a thorough inspection of your products.

by Mitti

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Device Sign Out Sheet

This Device Sign Out Sheet template helps teams document equipment issuance and returns for handhelds, radios, and other devices. Record device and radio IDs, issue and return dates, and the condition of equipment at each handover. Capture damage details, assign responsible managers, and require employee name and signature for accountability. Ideal for IT and facilities teams to standardize asset tracking, safeguard equipment, and maintain clear audit trails across the organization.

by Fernando Asencio, from the Community

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Medical Device Service Report

This medical device service report template helps technicians document field maintenance and repairs for UV phototherapy and similar equipment. Record scope of work, device and model details, serial numbers, lamp hours, intensity measurements, parts replaced, and whether work is under warranty. Log functional tests for cooling, lighting, sensors, and touchscreens, and calibrate modules with before-and-after readings in mW/cm2. Include photos of issues, note follow-up actions with timelines, itemize charges and total cost, and capture technician and owner signatures to confirm completion and next steps.

by Liam User, from the Community

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MB Backflow Device Report Template

Use this MB Backflow Device Report template to document backflow prevention device testing and compliance. Record property and site details, device make, model, serial number, size and type, and the date of test. Capture authorized tester credentials, licence number, and contact information, along with results and notes. Ideal for licensed plumbers and facilities teams to standardize reporting, maintain records for audits, and meet local codes and water authority requirements.

by Shane Stevanovich, from the Community

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ISO 13485:2016 Audit Checklist

A comprehensive ISO 13485:2016 audit checklist for medical device organizations. It guides internal auditors through quality management system requirements, including documentation control, management responsibility, resource and work environment controls, product realization, risk management, design and development, supplier evaluation, production and servicing, sterilization and sterile barrier validation, UDI and traceability, preservation, monitoring and measurement, calibration and software validation, feedback and complaints, internal audits, control of nonconforming product, analysis of data, and corrective and preventive actions. Ideal for audit preparation, gap assessments, and maintaining regulatory compliance across the medical device lifecycle.

by Tomas Langhout, from the Community

20+

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Template

ISO 13485:2016 Checklist for Medical Device QMS

This ISO 13485:2016 checklist helps quality managers evaluate and improve a medical device quality management system. Organized around clauses 4-8, it guides QMS documentation, management responsibility, resource and contamination control, product realization (design, purchasing, production, servicing, sterilization, traceability), and measurement and improvement. Use it to verify compliance, plan audits, track corrective and preventive actions, and maintain product safety and performance.

by THI XUAN TINH VO, from the Community

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Medical Device Audit

About author

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ISO 14971 Checklist

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ISO 13485:2016 Audit Checklist

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