SERVICES
Strategy & Advisory
Our strategy and advisory services provide the guidance and support you need to navigate the complex regulatory landscape, ensure compliance, and drive user-centered innovation in the MedTech industry. ClariMed’s expert advisors have honed their human factors knowledge and skillset over the years through involvement in FDA calls, participation within international standards committees, and experience applying the usability engineering process across medical device, combination product, and IVD products of various technologies and clinical indications.
From agency representation to gap analysis, human factors strategy design, and regulatory agency-worthy justifications for tailoring your usability engineering process and Human Factors validation study design, we help you achieve your business objectives while prioritizing patient and user safety and optimizing user satisfaction.
With a global network of usability experts and state-of-the-art facilities, ClariMed offers unmatched expertise and capabilities to optimize your medical product designs. Partner with us to leverage the power of human factors in your medical device development journey.
SERVICES
Strategy & Advisory
Our strategy and advisory services provide the guidance and support you need to navigate the complex regulatory landscape, ensure compliance, and drive user-centered innovation in the MedTech industry. ClariMed’s expert advisors have honed their human factors knowledge and skillset over the years through involvement in FDA calls, participation within international standards committees, and experience applying the usability engineering process across medical device, combination product, and IVD products of various technologies and clinical indications.
From agency representation to gap analysis, human factors strategy design, and regulatory agency-worthy justifications for tailoring your usability engineering process and Human Factors validation study design, we help you achieve your business objectives while prioritizing patient and user safety and optimizing user satisfaction.
With a global network of usability experts and state-of-the-art facilities, ClariMed offers unmatched expertise and capabilities to optimize your medical product designs. Partner with us to leverage the power of human factors in your medical device development journey.
SERVICES
Strategy & Advisory
Our strategy and advisory services provide the guidance and support you need to navigate the complex regulatory landscape, ensure compliance, and drive user-centered innovation in the MedTech industry. ClariMed’s expert advisors have honed their human factors knowledge and skillset over the years through involvement in FDA calls, participation within international standards committees, and experience applying the usability engineering process across medical device, combination product, and IVD products of various technologies and clinical indications.
From agency representation to gap analysis, human factors strategy design, and regulatory agency-worthy justifications for tailoring your usability engineering process and Human Factors validation study design, we help you achieve your business objectives while prioritizing patient and user safety and optimizing user satisfaction.
With a global network of usability experts and state-of-the-art facilities, ClariMed offers unmatched expertise and capabilities to optimize your medical product designs. Partner with us to leverage the power of human factors in your medical device development journey.
Agency Representation
Effectively communicate and collaborate with regulatory bodies through our expert agency representation.
Ensure your interests are represented in regulatory interactions
Receive guidance on regulatory strategies and requirements
Facilitate timely and effective communication with regulatory agencies
Agency Representation
Effectively communicate and collaborate with regulatory bodies through our expert agency representation.
Ensure your interests are represented in regulatory interactions
Receive guidance on regulatory strategies and requirements
Facilitate timely and effective communication with regulatory agencies
Agency Representation
Effectively communicate and collaborate with regulatory bodies through our expert agency representation.
Ensure your interests are represented in regulatory interactions
Receive guidance on regulatory strategies and requirements
Facilitate timely and effective communication with regulatory agencies
Gap Analysis
Identify areas for improvement and develop action plans to bridge the gaps in regulatory compliance and industry best practices, quality systems, and human factors engineering.
Assess gaps in compliance with regulations, international standards related to usability engineering and risk management (e.g., IEC 62366-1, IEC 60601-1-6, ISO 14971), FDA Guidance, and quality systems.
Prioritize areas for improvement based on impact and feasibility
Develop targeted action plans to address gaps and achieve desired state
Gap Analysis
Identify areas for improvement and develop action plans to bridge the gaps in regulatory compliance and industry best practices, quality systems, and human factors engineering.
Assess gaps in compliance with regulations, international standards related to usability engineering and risk management (e.g., IEC 62366-1, IEC 60601-1-6, ISO 14971), FDA Guidance, and quality systems.
Prioritize areas for improvement based on impact and feasibility
Develop targeted action plans to address gaps and achieve desired state
Gap Analysis
Identify areas for improvement and develop action plans to bridge the gaps in regulatory compliance and industry best practices, quality systems, and human factors engineering.
Assess gaps in compliance with regulations, international standards related to usability engineering and risk management (e.g., IEC 62366-1, IEC 60601-1-6, ISO 14971), FDA Guidance, and quality systems.
Prioritize areas for improvement based on impact and feasibility
Develop targeted action plans to address gaps and achieve desired state
Strategy Design
Develop comprehensive strategies that align regulatory, quality, and human factors considerations with your business objectives.
Align regulatory, quality, and human factors strategies with your business goals and regulatory body expectations
Identify key initiatives and priorities for successful human factors engineering implementation while keeping in mind regulations, international standards, and FDA Guidance.
Develop detailed implementation plans and timelines
Allocate resources and assign responsibilities for effective execution with input from our expert ClariMed advisors
Strategy Design
Develop comprehensive strategies that align regulatory, quality, and human factors considerations with your business objectives.
Align regulatory, quality, and human factors strategies with your business goals and regulatory body expectations
Identify key initiatives and priorities for successful human factors engineering implementation while keeping in mind regulations, international standards, and FDA Guidance.
Develop detailed implementation plans and timelines
Allocate resources and assign responsibilities for effective execution with input from our expert ClariMed advisors
Strategy Design
Develop comprehensive strategies that align regulatory, quality, and human factors considerations with your business objectives.
Align regulatory, quality, and human factors strategies with your business goals and regulatory body expectations
Identify key initiatives and priorities for successful human factors engineering implementation while keeping in mind regulations, international standards, and FDA Guidance.
Develop detailed implementation plans and timelines
Allocate resources and assign responsibilities for effective execution with input from our expert ClariMed advisors
Waivers & Justifications
Obtain regulatory agency approval for tailoring your human factors activities while ensuring safety and effectiveness through our waiver and justification support.
Identify situations where tailoring your human factors engineering effort may be appropriate
Develop strong rationale and compile supporting evidence for waiver requests to regulatory agencies
Demonstrate that alternative approaches are sound and ensure safety and effectiveness
Communicate effectively with regulatory agencies to obtain approval
Waivers & Justifications
Obtain regulatory agency approval for tailoring your human factors activities while ensuring safety and effectiveness through our waiver and justification support.
Identify situations where tailoring your human factors engineering effort may be appropriate
Develop strong rationale and compile supporting evidence for waiver requests to regulatory agencies
Demonstrate that alternative approaches are sound and ensure safety and effectiveness
Communicate effectively with regulatory agencies to obtain approval
Waivers & Justifications
Obtain regulatory agency approval for tailoring your human factors activities while ensuring safety and effectiveness through our waiver and justification support.
Identify situations where tailoring your human factors engineering effort may be appropriate
Develop strong rationale and compile supporting evidence for waiver requests to regulatory agencies
Demonstrate that alternative approaches are sound and ensure safety and effectiveness
Communicate effectively with regulatory agencies to obtain approval
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.