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Medical device product evaluation form

Medical device product evaluation form

Assess medical devices thoroughly with this form. Capture key details, document performance, and identify potential issues using one organized template.

Use this template
or download pdf
Medical device product evaluation form

Assess medical devices thoroughly with this form. Capture key details, document performance, and identify potential issues using one organized template.

Use this template
or download pdf

About the Medical device product evaluation form

Many medical device recalls come from issues that could’ve been identified during product evaluations. This medical device product evaluation form helps you catch potential problems early by organizing key performance, safety, and compliance data in one place. It’ll be easier for your team to document findings thoroughly and consistently, so you can cover all of the crucial details.

Improve quality with a medical device product evaluation form

The medical device product evaluation form guides you through key steps of the assessment process. It includes sections for general device information, performance metrics, safety evaluations, user experience feedback, and final recommendations.

With this template, you’ll benefit from a logical, easy-to-follow layout that makes evaluations more organized. It allows you to compile information effectively so you can identify trends, spot potential issues, and make data-driven decisions. The clear structure also helps improve team collaboration, as everyone follows the same process, reducing inconsistencies in reporting.

Plus, you can customize the form to match your unique evaluation criteria, and it’s flexible enough to suit different devices and workflows.

A step-by-step guide to using the medical device product evaluation form

This template streamlines the process so you can conduct thorough, consistent evaluations. Follow these steps to get the most out of it:

  1. Customize the template to match your evaluation criteria. Every medical device has unique performance and safety requirements. Adjust the form by adding or modifying fields to reflect key aspects such as regulatory compliance, usability, and durability. This ensures your assessments capture the most relevant data.
  2. Conduct a detailed device inspection. During testing, use the form to systematically record observations. Document performance metrics, functionality under different conditions, and any safety concerns. Be specific—clear, detailed input leads to better analysis later.
  3. Gather user feedback and real-world performance insights. Include input from end users, such as healthcare professionals or technicians, to capture real-world usability issues. This helps identify design flaws or operational challenges that might not be obvious in controlled testing.
  4. Review findings and flag critical issues. Once the form is completed, analyze the data for trends. Look for recurring defects, safety concerns, or performance inconsistencies. Highlight urgent issues that require immediate attention and escalate them to the appropriate teams.
  5. Store and track evaluations for future reference. Keep completed forms organized to compare assessments over time. Tracking evaluation history helps you refine testing protocols and improve decision-making for future product updates or approvals.

Upgrade your system for evaluating medical devices

Need a faster, more reliable way to assess medical devices? Use Lumiform’s medical device product evaluation form to document performance, flag issues, and keep assessments consistent. The organized layout lets you capture critical data at a glance, making it easy to compare results and make confident decisions.

Related categories

  • Operational excellence templates
  • General templates
  • Quality assurance templates
Preview of the template
Page 1
Device Information
Device Name
Device Model
Device Manufacturer
Regulatory Approval Status
Device Features
Ease of Use
Ergonomics
Safety Features
Portability
Cleaning/Sterilization
Performance Evaluation
Overall Functionality
Accuracy
Reliability
Speed of Operation
Durability
User Feedback
Clinician Satisfaction
Patient Satisfaction
Comments

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Related resources

Access a complete set of resources aimed at maximizing safety, quality, and operational excellence, including detailed guides, related templates, and real-world use cases.

Topic guides

Read in-depth guides covering key topics related to this article.

ISO 13485: A guide to quality management in medical devicesNavigating medical device regulations: Key steps for compliance A beginner's guide to MDSAP audits
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Frequently asked questions

What factors should I consider when evaluating a medical device?

When evaluating a medical device, focus on performance, safety, usability, and compliance. Test how well it functions under different conditions, then assess its safety by identifying potential hazards or malfunctions. Consider ease of use—devices should be intuitive for healthcare professionals. Finally, verify compliance with industry regulations to confirm it meets necessary standards.

What common issues are found during medical device assessments?

Frequent issues include inconsistent performance, user interface problems, and safety concerns. Devices may fail to work reliably across different environments or patient conditions. Poor design can lead to usability challenges, increasing the risk of errors. Safety flaws, such as electrical faults or material degradation, can also come up over time.

How can I compare different medical devices effectively?

To compare devices, use a systematic approach. Define key evaluation criteria such as performance, safety, user experience, and cost. Conduct side-by-side testing in real-world scenarios to assess reliability and ease of use. Gather feedback from healthcare professionals who will be using the device daily.


This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.
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