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. From agency representation to gap analysis, strategy design, and waiver justification, we help you achieve your business objectives while prioritizing patient safety and user satisfaction. 

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.  

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. From agency representation to gap analysis, strategy design, and waiver justification, we help you achieve your business objectives while prioritizing patient safety and user satisfaction. 

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.  

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. From agency representation to gap analysis, strategy design, and waiver justification, we help you achieve your business objectives while prioritizing patient safety and user satisfaction. 

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.  

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, quality systems, and human factors engineering. 

  • Assess gaps in regulatory compliance, quality systems, and human factors engineering 

  • 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, quality systems, and human factors engineering. 

  • Assess gaps in regulatory compliance, quality systems, and human factors engineering 

  • 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, quality systems, and human factors engineering. 

  • Assess gaps in regulatory compliance, quality systems, and human factors engineering 

  • 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 

  • Identify key initiatives and priorities for successful implementation 

  • Develop detailed implementation plans and timelines 

  • Allocate resources and assign responsibilities for effective execution 

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 

  • Identify key initiatives and priorities for successful implementation 

  • Develop detailed implementation plans and timelines 

  • Allocate resources and assign responsibilities for effective execution 

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 

  • Identify key initiatives and priorities for successful implementation 

  • Develop detailed implementation plans and timelines 

  • Allocate resources and assign responsibilities for effective execution 

Waivers & Justifications

Obtain approval for alternative approaches while ensuring safety and effectiveness through our waiver and justification support. 

  • Identify situations where waivers or justifications may be appropriate 

  • Develop strong rationale and compile supporting evidence for waiver requests 

  • Demonstrate that alternative approaches ensure safety and effectiveness 

  • Communicate effectively with regulatory agencies to obtain approval 

Waivers & Justifications

Obtain approval for alternative approaches while ensuring safety and effectiveness through our waiver and justification support. 

  • Identify situations where waivers or justifications may be appropriate 

  • Develop strong rationale and compile supporting evidence for waiver requests 

  • Demonstrate that alternative approaches ensure safety and effectiveness 

  • Communicate effectively with regulatory agencies to obtain approval 

Waivers & Justifications

Obtain approval for alternative approaches while ensuring safety and effectiveness through our waiver and justification support. 

  • Identify situations where waivers or justifications may be appropriate 

  • Develop strong rationale and compile supporting evidence for waiver requests 

  • Demonstrate that alternative approaches 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.