Collaborative Expertise for

Human-Centered Medical Solutions

At ClariMed, we seamlessly integrate our expertise with your team, creating a collaborative environment that drives innovation in medical device development. Our approach is centered on:

  • Understanding your intended users and the key stakeholders in the design process

  • Providing a holistic view of the environment where your device will be used

  • Navigating global regulatory pathways for usability engineering, regardless of product complexity

Our human-centered design approach ensures your products are not only safe and effective but resonate deeply with your target market.

Collaborative Expertise for

Human-Centered Medical Solutions

At ClariMed, we seamlessly integrate our expertise with your team, creating a collaborative environment that drives innovation in medical device development. Our approach is centered on:

  • Understanding your intended users and the key stakeholders in the design process

  • Providing a holistic view of the environment where your device will be used

  • Navigating global regulatory pathways for usability engineering, regardless of product complexity

Our human-centered design approach ensures your products are not only safe and effective but resonate deeply with your target market.

Collaborative Expertise for

Human-Centered Medical Solutions

At ClariMed, we seamlessly integrate our expertise with your team, creating a collaborative environment that drives innovation in medical device development. Our approach is centered on:

  • Understanding your intended users and the key stakeholders in the design process

  • Providing a holistic view of the environment where your device will be used

  • Navigating global regulatory pathways for usability engineering, regardless of product complexity

Our human-centered design approach ensures your products are not only safe and effective but resonate deeply with your target market.

Markets Served

Pharma/Biotech, MedDevice, Health Tech

Our human-centered design approach ensures your products are not only safe and effective but resonate deeply with your target market. We cover the entire health-tech spectrum, including:

  • Medical devices

  • Software as a medical device (SaMD)

  • AI as a medical device

  • Pharmaceuticals

  • Generics

  • Diagnostics

Within these markets, we will carefully craft your project team to ensure collaboration with highly skilled professionals in your specific design area. Despite being one of the largest human factors and market insights teams, we foster a personable environment where we become an extension of your own device development team.

Markets Served

Pharma/Biotech, MedDevice, Health Tech

Our human-centered design approach ensures your products are not only safe and effective but resonate deeply with your target market. We cover the entire health-tech spectrum, including:

  • Medical devices

  • Software as a medical device (SaMD)

  • AI as a medical device

  • Pharmaceuticals

  • Generics

  • Diagnostics

Within these markets, we will carefully craft your project team to ensure collaboration with highly skilled professionals in your specific design area. Despite being one of the largest human factors and market insights teams, we foster a personable environment where we become an extension of your own device development team.

Markets Served

Pharma/Biotech, MedDevice, Health Tech

Our human-centered design approach ensures your products are not only safe and effective but resonate deeply with your target market. We cover the entire health-tech spectrum, including:

  • Medical devices

  • Software as a medical device (SaMD)

  • AI as a medical device

  • Pharmaceuticals

  • Generics

  • Diagnostics

Within these markets, we will carefully craft your project team to ensure collaboration with highly skilled professionals in your specific design area. Despite being one of the largest human factors and market insights teams, we foster a personable environment where we become an extension of your own device development team.

Therapeutic Areas

With a global team of 70 consultants, including 7 world-leading experts, we bring unparalleled expertise to every project. Our diverse knowledge spans numerous therapy areas, allowing us to craft the perfect project team tailored to your specific needs. These therapy areas include:

  • Cardiology (EP, Interventional)

  • Neurology

  • Wound Care & Dermatology

  • Hematology & Chemistry

  • Ophthalmology / Optometry

  • Vascular (Cardio, Neuro, & Peripheral)

  • General Surgery

  • Emergency Medicine

From people with decades of engineering experience to former healthcare professionals, our team brings a wealth of knowledge in human-centered design, development, and regulatory services. We are driven by a desire to make medical devices simple, safe, and effective while intuitively resonating with the user and intended market.

Therapeutic Areas

With a global team of 70 consultants, including 7 world-leading experts, we bring unparalleled expertise to every project. Our diverse knowledge spans numerous therapy areas, allowing us to craft the perfect project team tailored to your specific needs. These therapy areas include:

  • Cardiology (EP, Interventional)

  • Neurology

  • Wound Care & Dermatology

  • Hematology & Chemistry

  • Ophthalmology / Optometry

  • Vascular (Cardio, Neuro, & Peripheral)

  • General Surgery

  • Emergency Medicine

From people with decades of engineering experience to former healthcare professionals, our team brings a wealth of knowledge in human-centered design, development, and regulatory services. We are driven by a desire to make medical devices simple, safe, and effective while intuitively resonating with the user and intended market.

Therapeutic Areas

With a global team of 70 consultants, including 7 world-leading experts, we bring unparalleled expertise to every project. Our diverse knowledge spans numerous therapy areas, allowing us to craft the perfect project team tailored to your specific needs. These therapy areas include:

  • Cardiology (EP, Interventional)

  • Neurology

  • Wound Care & Dermatology

  • Hematology & Chemistry

  • Ophthalmology / Optometry

  • Vascular (Cardio, Neuro, & Peripheral)

  • General Surgery

  • Emergency Medicine

From people with decades of engineering experience to former healthcare professionals, our team brings a wealth of knowledge in human-centered design, development, and regulatory services. We are driven by a desire to make medical devices simple, safe, and effective while intuitively resonating with the user and intended market.

Device Types

From prefilled syringes to complex robotic surgery systems, we have a breadth of experience implementing the usability engineering process for medical devices and combination products for small start-ups through Fortune 500 companies, and everything in-between. By partnering with us early in the development process, we can provide valuable insights from your competitors and push the boundaries of creating exemplary, usable devices.
 
Combination Products 

  • Injection Devices (Autoinjectors, Pen Injectors, Prefilled Syringes)  

  • Transfer Devices Inhalation Devices  

Medical Devices

  • Anesthetic Applicators 

  • Apps for Imaging Systems 

  • Breath Analyzers 

  • Bronchoscope Systems 

  • Cardiac Mapping Systems

  • Catheter / Generator Systems 

  • Electrical Stimulation Systems 

  • In Vitro Diagnostics 

  • Interventional Products 

  • Laparoscopic Instruments 

  • Optometry Diagnostic Devices 

  • Resuscitation Devices 

  • Robotic Surgery Systems 

  • Ventilators 

  • Wound Therapy Systems 

Partner with us to leverage our expertise in medical device development and human factors engineering, and discover how we can help you bring safe, effective, and user-centered products to market.

Device Types

From prefilled syringes to complex robotic surgery systems, we have a breadth of experience implementing the usability engineering process for medical devices and combination products for small start-ups through Fortune 500 companies, and everything in-between. By partnering with us early in the development process, we can provide valuable insights from your competitors and push the boundaries of creating exemplary, usable devices.
 
Combination Products 

  • Injection Devices (Autoinjectors, Pen Injectors, Prefilled Syringes)  

  • Transfer Devices Inhalation Devices  

Medical Devices

  • Anesthetic Applicators 

  • Apps for Imaging Systems 

  • Breath Analyzers 

  • Bronchoscope Systems 

  • Cardiac Mapping Systems

  • Catheter / Generator Systems 

  • Electrical Stimulation Systems 

  • In Vitro Diagnostics 

  • Interventional Products 

  • Laparoscopic Instruments 

  • Optometry Diagnostic Devices 

  • Resuscitation Devices 

  • Robotic Surgery Systems 

  • Ventilators 

  • Wound Therapy Systems 

Partner with us to leverage our expertise in medical device development and human factors engineering, and discover how we can help you bring safe, effective, and user-centered products to market.

Device Types

From prefilled syringes to complex robotic surgery systems, we have a breadth of experience implementing the usability engineering process for medical devices and combination products for small start-ups through Fortune 500 companies, and everything in-between. By partnering with us early in the development process, we can provide valuable insights from your competitors and push the boundaries of creating exemplary, usable devices.
 
Combination Products 

  • Injection Devices (Autoinjectors, Pen Injectors, Prefilled Syringes)  

  • Transfer Devices Inhalation Devices  

Medical Devices

  • Anesthetic Applicators 

  • Apps for Imaging Systems 

  • Breath Analyzers 

  • Bronchoscope Systems 

  • Cardiac Mapping Systems

  • Catheter / Generator Systems 

  • Electrical Stimulation Systems 

  • In Vitro Diagnostics 

  • Interventional Products 

  • Laparoscopic Instruments 

  • Optometry Diagnostic Devices 

  • Resuscitation Devices 

  • Robotic Surgery Systems 

  • Ventilators 

  • Wound Therapy Systems 

Partner with us to leverage our expertise in medical device development and human factors engineering, and discover how we can help you bring safe, effective, and user-centered products to market.

Regulations & Standards Compliance

Our consultants have deep expertise in ensuring compliance with all relevant regulations, standards, and guidelines related to the usability engineering process.

We actively participate in the development of human factors standards through our involvement with the AAMI Human Factors Engineering Committee and the International Standards Committee (IEC 62A Joint Working Group 4).

We have experience with the following regulations, standards, and guidelines:

  • 21 CFR Part 820.30 (c), (d), & (f)

  • EU Medical Device Regulation (2017/745)

  • IEC 62366-1:2015 & IEC62366:2007/A1 (2014)

  • ISO 14971:2007, 2012, & 2019

  • IEC 60601-1-6

  • FDA: Applying Human Factors and Usability Engineering to Medical Devices

  • FDA: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development (DRAFT)

  • FDA: List of Highest Priority Devices for Human Factors Review (DRAFT)

  • MHRA: Human Factors and Usability Engineering - Guidance for Medical Devices Including Drug-device Combination Products

Regulations & Standards Compliance

Our consultants have deep expertise in ensuring compliance with all relevant regulations, standards, and guidelines related to the usability engineering process.

We actively participate in the development of human factors standards through our involvement with the AAMI Human Factors Engineering Committee and the International Standards Committee (IEC 62A Joint Working Group 4).

We have experience with the following regulations, standards, and guidelines:

  • 21 CFR Part 820.30 (c), (d), & (f)

  • EU Medical Device Regulation (2017/745)

  • IEC 62366-1:2015 & IEC62366:2007/A1 (2014)

  • ISO 14971:2007, 2012, & 2019

  • IEC 60601-1-6

  • FDA: Applying Human Factors and Usability Engineering to Medical Devices

  • FDA: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development (DRAFT)

  • FDA: List of Highest Priority Devices for Human Factors Review (DRAFT)

  • MHRA: Human Factors and Usability Engineering - Guidance for Medical Devices Including Drug-device Combination Products

Regulations & Standards Compliance

Our consultants have deep expertise in ensuring compliance with all relevant regulations, standards, and guidelines related to the usability engineering process.

We actively participate in the development of human factors standards through our involvement with the AAMI Human Factors Engineering Committee and the International Standards Committee (IEC 62A Joint Working Group 4).

We have experience with the following regulations, standards, and guidelines:

  • 21 CFR Part 820.30 (c), (d), & (f)

  • EU Medical Device Regulation (2017/745)

  • IEC 62366-1:2015 & IEC62366:2007/A1 (2014)

  • ISO 14971:2007, 2012, & 2019

  • IEC 60601-1-6

  • FDA: Applying Human Factors and Usability Engineering to Medical Devices

  • FDA: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development (DRAFT)

  • FDA: List of Highest Priority Devices for Human Factors Review (DRAFT)

  • MHRA: Human Factors and Usability Engineering - Guidance for Medical Devices Including Drug-device Combination Products

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.