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
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
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
Markets Served
Pharma/Biotech, MedDevice, Health Tech
Our human-centered design approach ensures your products are not only safe and effective deeply with your target market. We cover the entire health-tech spectrum, including:
Medical devices
Combination Products
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 deeply with your target market. We cover the entire health-tech spectrum, including:
Medical devices
Combination Products
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 deeply with your target market. We cover the entire health-tech spectrum, including:
Medical devices
Combination Products
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, but are not limited to:
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, but are not limited to:
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, but are not limited to:
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. Throughout the years, we have worked with teams developing combination products, implants, interventional products, life support systems, image systems, and so much more. By partnering with us early in the development process, we can provide valuable insights from our vast experience and push the boundaries of creating exemplary, usable devices.
Combination Products
Injection Devices (Autoinjectors, Pen Injectors, Prefilled Syringes)
Transfer Devices
Inhalation Devices
Infusion Pumps
Medical Devices
Ablation Systems (Catheter / Generation Systems)
Anesthetic Applicators
Apps for Imaging Systems
Breath Analyzers
Bronchoscope Systems
Cardiac Mapping Systems
Implantable Electrical Stimulation Systems (brain, nerve, spinal)
Endoscope Systems
Imaging Systems (IVUS, US)
Electrical Stimulation Systems
In Vitro Diagnostics
Interventional Catheter-Based Products
Laparoscopic Instruments
Optometry Diagnostic Devices
Resuscitation Devices
Robotic Surgery Systems
Ventilators
Wound Therapy Systems
And More!
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. Throughout the years, we have worked with teams developing combination products, implants, interventional products, life support systems, image systems, and so much more. By partnering with us early in the development process, we can provide valuable insights from our vast experience and push the boundaries of creating exemplary, usable devices.
Combination Products
Injection Devices (Autoinjectors, Pen Injectors, Prefilled Syringes)
Transfer Devices
Inhalation Devices
Infusion Pumps
Medical Devices
Ablation Systems (Catheter / Generation Systems)
Anesthetic Applicators
Apps for Imaging Systems
Breath Analyzers
Bronchoscope Systems
Cardiac Mapping Systems
Implantable Electrical Stimulation Systems (brain, nerve, spinal)
Endoscope Systems
Imaging Systems (IVUS, US)
Electrical Stimulation Systems
In Vitro Diagnostics
Interventional Catheter-Based Products
Laparoscopic Instruments
Optometry Diagnostic Devices
Resuscitation Devices
Robotic Surgery Systems
Ventilators
Wound Therapy Systems
And More!
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. Throughout the years, we have worked with teams developing combination products, implants, interventional products, life support systems, image systems, and so much more. By partnering with us early in the development process, we can provide valuable insights from our vast experience and push the boundaries of creating exemplary, usable devices.
Combination Products
Injection Devices (Autoinjectors, Pen Injectors, Prefilled Syringes)
Transfer Devices
Inhalation Devices
Infusion Pumps
Medical Devices
Ablation Systems (Catheter / Generation Systems)
Anesthetic Applicators
Apps for Imaging Systems
Breath Analyzers
Bronchoscope Systems
Cardiac Mapping Systems
Implantable Electrical Stimulation Systems (brain, nerve, spinal)
Endoscope Systems
Imaging Systems (IVUS, US)
Electrical Stimulation Systems
In Vitro Diagnostics
Interventional Catheter-Based Products
Laparoscopic Instruments
Optometry Diagnostic Devices
Resuscitation Devices
Robotic Surgery Systems
Ventilators
Wound Therapy Systems
And More!
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 guidance:
21 CFR Part 820.30 (c), (d), & (f)
EU Medical Device Regulation (MDR) (2017/745)
EU In Vitro Diagnostic Regulation (IVDR) (2017/746)
IEC 62366-1
ISO 14971
IEC 60601-1-6
FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices
FDA Guidance: Application of Human Factors Engineering Principles for Combination Products: Questions and Answers
FDA Draft Guidance: Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA
FDA Draft Guidance: Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications
FDA Draft Guidance: Content of Human Factors Information in Medical Device Marketing Submissions
FDA Draft Guidance: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development
MHRA: Human Factors and Usability Engineering - Guidance for Medical Devices Including Drug-device Combination Products
China NMPA: Medical Devices Usability Engineering Guidelines and More!
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 guidance:
21 CFR Part 820.30 (c), (d), & (f)
EU Medical Device Regulation (MDR) (2017/745)
EU In Vitro Diagnostic Regulation (IVDR) (2017/746)
IEC 62366-1
ISO 14971
IEC 60601-1-6
FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices
FDA Guidance: Application of Human Factors Engineering Principles for Combination Products: Questions and Answers
FDA Draft Guidance: Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA
FDA Draft Guidance: Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications
FDA Draft Guidance: Content of Human Factors Information in Medical Device Marketing Submissions
FDA Draft Guidance: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development
MHRA: Human Factors and Usability Engineering - Guidance for Medical Devices Including Drug-device Combination Products
China NMPA: Medical Devices Usability Engineering Guidelines and More!
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 guidance:
21 CFR Part 820.30 (c), (d), & (f)
EU Medical Device Regulation (MDR) (2017/745)
EU In Vitro Diagnostic Regulation (IVDR) (2017/746)
IEC 62366-1
ISO 14971
IEC 60601-1-6
FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices
FDA Guidance: Application of Human Factors Engineering Principles for Combination Products: Questions and Answers
FDA Draft Guidance: Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA
FDA Draft Guidance: Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications
FDA Draft Guidance: Content of Human Factors Information in Medical Device Marketing Submissions
FDA Draft Guidance: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development
MHRA: Human Factors and Usability Engineering - Guidance for Medical Devices Including Drug-device Combination Products
China NMPA: Medical Devices Usability Engineering Guidelines and More!
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.