EVIDENCE BASED TESTING TO

Enhance Medical Product Efficacy and Safety

From expert human factors review of early prototypes to end-to-end formative testing in preparation for your validation study, we help you optimize your medical product design through the usability engineering process. 

  • Formative Usability Study Preparation, Coordination and Execution & Reporting 

  • Participant Recruitment for Usability Studies (Lay Users & Healthcare Professionals) 

  • Design Improvements or Expert Review of Medical Product User Interfaces 

  • Cognitive Walk Throughs 

  • Surveys 

With a global network of usability experts and state-of-the-art facilities, ClariMed offers unmatched expertise in optimizing your medical product designs. Partner with us to leverage the power of human factors in your medical device development journey.  

EVIDENCE BASED TESTING TO

Enhance Medical Product Efficacy and Safety

From expert human factors review of early prototypes to end-to-end formative testing in preparation for your validation study, we help you optimize your medical product design through the usability engineering process. 

  • Formative Usability Study Preparation, Coordination and Execution & Reporting 

  • Participant Recruitment for Usability Studies (Lay Users & Healthcare Professionals) 

  • Design Improvements or Expert Review of Medical Product User Interfaces 

  • Cognitive Walk Throughs 

  • Surveys 

With a global network of usability experts and state-of-the-art facilities, ClariMed offers unmatched expertise in optimizing your medical product designs. Partner with us to leverage the power of human factors in your medical device development journey.  

EVIDENCE BASED TESTING TO

Enhance Medical Product Efficacy and Safety

From expert human factors review of early prototypes to end-to-end formative testing in preparation for your validation study, we help you optimize your medical product design through the usability engineering process. 

  • Formative Usability Study Preparation, Coordination and Execution & Reporting 

  • Participant Recruitment for Usability Studies (Lay Users & Healthcare Professionals) 

  • Design Improvements or Expert Review of Medical Product User Interfaces 

  • Cognitive Walk Throughs 

  • Surveys 

With a global network of usability experts and state-of-the-art facilities, ClariMed offers unmatched expertise in optimizing your medical product designs. Partner with us to leverage the power of human factors in your medical device development journey.  

HF VALIDATION

Optimizing medical device usability for safety and effectiveness

The Human Factors Validation process evaluates medical device usability to ensure safety, effectiveness, and ease of use for intended users in their environment. The focus includes:

  • Identifying usability issues early in development

  • Optimizing design for enhanced user experience

  • Reducing use errors and associated risks

  • Gathering user feedback to inform design decisions

  • Ensuring compliance with usability regulations

By addressing usability early, this process optimizes your device design, enhancing user experience and regulatory compliance.

Contact us to leverage our HF Validation expertise for your medical device's success.

HF VALIDATION

Optimizing medical device usability for safety and effectiveness

The Human Factors Validation process evaluates medical device usability to ensure safety, effectiveness, and ease of use for intended users in their environment. The focus includes:

  • Identifying usability issues early in development

  • Optimizing design for enhanced user experience

  • Reducing use errors and associated risks

  • Gathering user feedback to inform design decisions

  • Ensuring compliance with usability regulations

By addressing usability early, this process optimizes your device design, enhancing user experience and regulatory compliance.

Contact us to leverage our HF Validation expertise for your medical device's success.

HF VALIDATION

Optimizing medical device usability for safety and effectiveness

The Human Factors Validation process evaluates medical device usability to ensure safety, effectiveness, and ease of use for intended users in their environment. The focus includes:

  • Identifying usability issues early in development

  • Optimizing design for enhanced user experience

  • Reducing use errors and associated risks

  • Gathering user feedback to inform design decisions

  • Ensuring compliance with usability regulations

By addressing usability early, this process optimizes your device design, enhancing user experience and regulatory compliance.

Contact us to leverage our HF Validation expertise for your medical device's success.

DESIGN VALIDATION

Ensuring medical devices meet user needs and intended use

The Human Factors Engineers at ClariMed bring a unique perspective to Design Validation, focusing on user needs, usability, and real-world performance. The offerings encompass a full range of Design Validation services, including:

  • User needs validation 

  • Design performance evaluation 

  • Functionality testing 

  • Human Factors/Usability validation studies 

Continually assessing and improving a medical device’s design, we help maintain alignment with user expectations and intended use. 

This is not a one-time process. Device design changes, whether due to post-market surveillance data, customer feedback, complaints, corrective or preventive actions (CAPAs), risk management updates, or any other factors. Therefore, the validation processes must be revisited and updated accordingly. This commitment to continuous improvement ensures that devices remain safe, effective, and aligned with user needs throughout their lifecycle. 

Contact us to discover how our Design Validation expertise can benefit your medical device.

DESIGN VALIDATION

Ensuring medical devices meet user needs and intended use

The Human Factors Engineers at ClariMed bring a unique perspective to Design Validation, focusing on user needs, usability, and real-world performance. The offerings encompass a full range of Design Validation services, including:

  • User needs validation 

  • Design performance evaluation 

  • Functionality testing 

  • Human Factors/Usability validation studies 

Continually assessing and improving a medical device’s design, we help maintain alignment with user expectations and intended use. 

This is not a one-time process. Device design changes, whether due to post-market surveillance data, customer feedback, complaints, corrective or preventive actions (CAPAs), risk management updates, or any other factors. Therefore, the validation processes must be revisited and updated accordingly. This commitment to continuous improvement ensures that devices remain safe, effective, and aligned with user needs throughout their lifecycle. 

Contact us to discover how our Design Validation expertise can benefit your medical device.

DESIGN VALIDATION

Ensuring medical devices meet user needs and intended use

The Human Factors Engineers at ClariMed bring a unique perspective to Design Validation, focusing on user needs, usability, and real-world performance. The offerings encompass a full range of Design Validation services, including:

  • User needs validation 

  • Design performance evaluation 

  • Functionality testing 

  • Human Factors/Usability validation studies 

Continually assessing and improving a medical device’s design, we help maintain alignment with user expectations and intended use. 

This is not a one-time process. Device design changes, whether due to post-market surveillance data, customer feedback, complaints, corrective or preventive actions (CAPAs), risk management updates, or any other factors. Therefore, the validation processes must be revisited and updated accordingly. This commitment to continuous improvement ensures that devices remain safe, effective, and aligned with user needs throughout their lifecycle. 

Contact us to discover how our Design Validation expertise can benefit your medical device.

Market Claims

Substantiate your product marketing messages with scientific evidence and build credibility with customers and healthcare professionals. 

  • Support marketing messages with rigorous scientific evidence 

  • Differentiate your products from competitors 

  • Reduce the risk of legal challenges or regulatory enforcement actions 

  • Demonstrate a commitment to transparency and responsible marketing practices 

Contact us to discover how our Market Claims expertise can benefit your medical device.

Market Claims

Substantiate your product marketing messages with scientific evidence and build credibility with customers and healthcare professionals. 

  • Support marketing messages with rigorous scientific evidence 

  • Differentiate your products from competitors 

  • Reduce the risk of legal challenges or regulatory enforcement actions 

  • Demonstrate a commitment to transparency and responsible marketing practices 

Contact us to discover how our Market Claims expertise can benefit your medical device.

Market Claims

Substantiate your product marketing messages with scientific evidence and build credibility with customers and healthcare professionals. 

  • Support marketing messages with rigorous scientific evidence 

  • Differentiate your products from competitors 

  • Reduce the risk of legal challenges or regulatory enforcement actions 

  • Demonstrate a commitment to transparency and responsible marketing practices 

Contact us to discover how our Market Claims expertise can benefit your medical device.

Low-risk Clinical/HF Studies

Gather real-world evidence of device safety, effectiveness, and usability in a clinical setting to support regulatory submissions and inform device design improvements.

  • Identify potential use-related risks and unintended consequences in a clinical setting

  • Support regulatory submissions and market approval for low-risk devices

  • Inform device design improvements and user training programs

  • Build confidence in device performance and user acceptance prior to full-scale clinical trials

Contact us to discover how our expertise can benefit your medical device.

Low-risk Clinical/HF Studies

Gather real-world evidence of device safety, effectiveness, and usability in a clinical setting to support regulatory submissions and inform device design improvements.

  • Identify potential use-related risks and unintended consequences in a clinical setting

  • Support regulatory submissions and market approval for low-risk devices

  • Inform device design improvements and user training programs

  • Build confidence in device performance and user acceptance prior to full-scale clinical trials

Contact us to discover how our expertise can benefit your medical device.

Low-risk Clinical/HF Studies

Gather real-world evidence of device safety, effectiveness, and usability in a clinical setting to support regulatory submissions and inform device design improvements.

  • Identify potential use-related risks and unintended consequences in a clinical setting

  • Support regulatory submissions and market approval for low-risk devices

  • Inform device design improvements and user training programs

  • Build confidence in device performance and user acceptance prior to full-scale clinical trials

Contact us to discover how our expertise can benefit your medical device.

Let's work together!

Contact us to discuss how we can advance your medical device development efforts together.

Let's work together!

Contact us to discuss how we can advance your medical device development efforts together.

Let's work together!

Contact us to discuss how we can advance your medical device development efforts together.