Need Expert Help with Usability or Regulatory Strategy?

Book a free 30-minute session with our human factors and design experts.

Schedule Your Free Strategy Session

Need Expert Help with Usability or Regulatory Strategy?

Book a free 30-minute session with our human factors and design experts.

Schedule Your Free Strategy Session

Even
The Best Ideas
Need Testing

Human Factors and Usability for Medical Technologies.

Schedule Your Free Strategy Session

Medical Technologies Testing with Personell

Our Services

Usability Facility Rental

We are partnered with University of Utah Health's Center for Patient Simulation. This fully staffed state-of-the-art facility has areas that represent realistic clinical environments equipped with medical devices used in clinical practice, high fidelity patient simulators, one-way mirrors for investigator observation, and a full suite of audio-video recording technologies.

Usability Facility Rental

Clinician Recruiting

Our experts are able to recruit clinicians for your usability evaluation. We can recruit from a variety of healthcare settings, different hospitals and clinics, with a range of experience and demographics.

Clinician Recruiting

Use Specifications

Our human factors and biomedical engineering experts help you identify the different intended users, work flows, clinician mental models to define and refine the capabilities of your technology.

Use Specifications

Our human factors and biomedical engineering experts help you identify the different intended users, work flows, clinician mental models to define and refine the capabilities of your technology.

Use Specifications

Our human factors and biomedical engineering experts help you identify the different intended users, work flows, clinician mental models to define and refine the capabilities of your technology.

Formative Usability Evaluation with Iterative Design

We apply HFE principles to effectively evaluate the strengths and areas of improvements during the iterative interface design process.

Formative Usability Evaluation with Iterative Design

We apply HFE principles to effectively evaluate the strengths and areas of improvements during the iterative interface design process.

Formative Usability Evaluation with Iterative Design

We apply HFE principles to effectively evaluate the strengths and areas of improvements during the iterative interface design process.

Formative Usability Evaluation with Iterative Design

We apply HFE principles to effectively evaluate the strengths and areas of improvements during the iterative interface design process.

Summative Usability Evaluation to Ensure Safety

We plan and execute the final Summative/Validation Testing to meet specific requirements of your medical technology, considering participant sample size, critical evaluation tasks tied to risk analysis, realistic simulation to ensure clinical relevance.

Summative Usability Evaluation to Ensure Safety

Regulatory Guidance

We ensure companies understand what is required for regulatory approval of their technology. We emphasize compliance with ISO 14971, and implement the necessary processes in IEC 62366-1.

Regulatory Guidance

We ensure companies understand what is required for regulatory approval of their technology. We emphasize compliance with ISO 14971, and implement the necessary processes in IEC 62366-1.

User Interface and Product Design

We have expert designers who are highly experienced in designing medical technology products. Our human factors teams work closely with the designers to develop an integrated risk analysis.

User Interface and Product Design

We have expert designers who are highly experienced in designing medical technology products. Our human factors teams work closely with the designers to develop an integrated risk analysis.

User Interface and Product Design

We have expert designers who are highly experienced in designing medical technology products. Our human factors teams work closely with the designers to develop an integrated risk analysis.

Use-Related Risk Analysis

Our bioengineering and human factors experts will systematically create a required risk analysis of your technology by linking user tasks and workflows to potential hazards.

Use-Related Risk Analysis

Our bioengineering and human factors experts will systematically create a required risk analysis of your technology by linking user tasks and workflows to potential hazards.

Regulatory Guidance

We ensure companies understand what is required for regulatory approval of their technology. We emphasize compliance with ISO 14971, and implement the necessary processes in IEC 62366-1.

Regulatory Guidance

We ensure companies understand what is required for regulatory approval of their technology. We emphasize compliance with ISO 14971, and implement the necessary processes in IEC 62366-1.

Use-Related Risk Analysis

Our bioengineering and human factors experts will systematically create a required risk analysis of your technology by linking user tasks and workflows to potential hazards.

Use-Related Risk Analysis

Our bioengineering and human factors experts will systematically create a required risk analysis of your technology by linking user tasks and workflows to potential hazards.

Usability Engineering Documentation

We create comprehensive documentation as part of a regulatory submission.

Usability Engineering Documentation

We create comprehensive documentation as part of a regulatory submission.

Usability Engineering Documentation

We create comprehensive documentation as part of a regulatory submission.

Have Your Own Human Factors Team?

Great! We can provide you with Facility Space, Clinician Recruiting, and IRB Review of your Study Protocols.

Book Consultation

Achieves Regulatory Compliance

and streamlines crucial market approval processes.

FDA

UKCA

CE

ISO 13485 (usability)

IEC 62366-1

Reduces The Risk Of Costly Recalls

and user-related liability issues.

Enhances Patient Safety

by mitigating and preventing potential use errors.

Drives Market Strategy And Success

through superior ease of use and user acceptance.

Improves Clinical Efficiency

for healthcare professionals and patient caregivers.

Lowers Overall
Development Costs

by fixing design flaws early in the process.

Reduces Training Time

and user reliance on lengthy instructions for use.

Why Usability Testing?

Achieves Regulatory Compliance

and streamlines crucial market approval processes.

FDA

UKCA

CE

ISO 13485 (usability)

IEC 62366-1

Reduces The Risk Of Costly Recalls

and user-related liability issues.

Enhances Patient Safety

by mitigating and preventing potential use errors.

Drives Market Strategy And Success

through superior ease of use and user acceptance.

Improves Clinical Efficiency

for healthcare professionals and patient caregivers.

Lowers Overall
Development Costs

by fixing design flaws early in the process.

Reduces Training Time

and user reliance on lengthy instructions for use.

Why Usability Testing?

Achieves Regulatory Compliance

and streamlines crucial market approval processes.

FDA

UKCA

CE

ISO 13485 (usability)

IEC 62366-1

Reduces The Risk Of Costly Recalls

and user-related liability issues.

Enhances Patient Safety

by mitigating and preventing potential use errors.

Drives Market Strategy And Success

through superior ease of use and user acceptance.

Improves Clinical Efficiency

for healthcare professionals and patient caregivers.

Lowers Overall
Development Costs

by fixing design flaws early in the process.

Reduces Training Time

and user reliance on lengthy instructions for use.

Why Usability Testing?

Medical Technologies We Evaluate

Anesthesia Machines

Medical Information Displays

AI-assisted and AI driven applications

Point of Care IT Systems

Infusion Pumps

Clinical Decision Support Systems

Patient Monitors

Code Carts

Critical Care Ventilators

Advanced Displays

Medication Documentation Systems

... And Many More!

Who We Are

Medvis is a specialized team of designers, biomedical engineers, human factors experts, clinical recruiters, designers, and biomedical engineers with over 25 years of experience in usability testing for medical devices.

25+ Years Experience

Human Factor Experts

Regulatory Experts

Biomedical Engineers