Envisioning the future of health
Envisioning the future of health
Your partner in human-centered medical device, combination product, and IVD development.
Your partner in human-centered medical device, combination product, and IVD development.
Iterative Design Perfected
Our iterative approach to device development, driven by usability and human factors, optimizes efficiency, mitigates risks, and ensures accessibility for maximum adoption.
Our iterative approach to device development, driven by usability and human factors, optimizes efficiency, mitigates risks, and ensures accessibility for maximum adoption.
SERVICES
Accelerating medical innovation
From early-stage user needs assessments and contextual inquiries to comprehensive human factors validation testing and regulatory support, we provide end-to-end solutions that prioritize safety, efficacy, and satisfaction.
Select services
Evidence Based Testing
HF Validation
Assess your device's ease of use, effectiveness, and user satisfaction through rigorous usability testing.
Quality Services
QMS
Implement a robust quality management system tailored to your specific needs and regulatory requirements.
Human Factors & Usability Studies
Market Insights
Uncover valuable market trends, customer preferences, and competetive landscapes to inform your device strategy.
Evidence Based Testing
Design Validation
Confirm that your device's design meets user needs, regulatory requirement, and performance goals.
Evidence Based Testing
Marketing Claims
Substantiate your device's marketing claims through carefully designed studies and data collection.
SERVICES
Accelerating medical innovation
From early-stage user needs assessments and contextual inquiries to comprehensive human factors validation testing and regulatory support, we provide end-to-end solutions that prioritize safety, efficacy, and satisfaction.
Select services
Evidence Based Testing
HF Validation
Assess your device's ease of use, effectiveness, and user satisfaction through rigorous usability testing.
Quality Services
QMS
Implement a robust quality management system tailored to your specific needs and regulatory requirements.
Human Factors & Usability Studies
Market Insights
Uncover valuable market trends, customer preferences, and competetive landscapes to inform your device strategy.
Evidence Based Testing
Design Validation
Confirm that your device's design meets user needs, regulatory requirement, and performance goals.
Evidence Based Testing
Marketing Claims
Substantiate your device's marketing claims through carefully designed studies and data collection.
SERVICES
Accelerating medical innovation
From early-stage user needs assessments and contextual inquiries to comprehensive human factors validation testing and regulatory support, we provide end-to-end solutions that prioritize safety, efficacy, and satisfaction.
Select services
Evidence Based Testing
HF Validation
Assess your device's ease of use, effectiveness, and user satisfaction through rigorous usability testing.
Quality Services
QMS
Implement a robust quality management system tailored to your specific needs and regulatory requirements.
Human Factors & Usability Studies
Market Insights
Uncover valuable market trends, customer preferences, and competetive landscapes to inform your device strategy.
Evidence Based Testing
Design Validation
Confirm that your device's design meets user needs, regulatory requirement, and performance goals.
Evidence Based Testing
Marketing Claims
Substantiate your device's marketing claims through carefully designed studies and data collection.
CAREERS
Join our team
Experienced Professionals
We foster a collaborative, inclusive, and dynamic work environment where creativity, expertise, and passion thrive.
Co-op Students
Our co-op and internship program offers hands-on experience in a fast-paced, dynamic environment. Participants work alongside our experienced team members.
CAREERS
Join our team
Experienced Professionals
We foster a collaborative, inclusive, and dynamic work environment where creativity, expertise, and passion thrive.
Co-op Students
Our co-op and internship program offers hands-on experience in a fast-paced, dynamic environment. Participants work alongside our experienced team members.
CAREERS
Join our team
Experienced Professionals
We foster a collaborative, inclusive, and dynamic work environment where creativity, expertise, and passion thrive.
Co-op Students
Our co-op and internship program offers hands-on experience in a fast-paced, dynamic environment. Participants work alongside our experienced team members.
SOLUTIONS
Tailored solutions, expertly delivered
From targeted project assistance to ongoing critical function management, our flexible approach ensures you have the right resources at the right time.
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SOLUTIONS
Tailored solutions, expertly delivered
From targeted project assistance to ongoing critical function management, our flexible approach ensures you have the right resources at the right time.
SOLUTIONS
Tailored solutions, expertly delivered
From targeted project assistance to ongoing critical function management, our flexible approach ensures you have the right resources at the right time.
INFLUENCE DESIGN INNOVATION
Share your valuable perspective
INFLUENCE DESIGN INNOVATION
Share your valuable perspective
INFLUENCE DESIGN INNOVATION
Share your valuable perspective
EXPERTISE
Deep knowledge across industries and therapeutic areas
Our team brings deep knowledge and experience in a wide range of medical device types, markets and therapeutic applications.
EXPERTISE
Deep knowledge across industries and therapeutic areas
Our team brings deep knowledge and experience in a wide range of medical device types, markets and therapeutic applications.
EXPERTISE
Deep knowledge across industries and therapeutic areas
Our team brings deep knowledge and experience in a wide range of medical device types, markets and therapeutic applications.
WHAT WE ARE
Advancing Medical Device Development and Regulatory Excellence
Accelerating time to market, improving safety, and enabling innovation for pharmaceutical and medtech teams, whilst enhancing outcomes and enriching the quality of life for their users.
WHAT WE ARE
Advancing Medical Device Development and Regulatory Excellence
Accelerating time to market, improving safety, and enabling innovation for pharmaceutical and medtech teams, whilst enhancing outcomes and enriching the quality of life for their users.
WHAT WE ARE
Advancing Medical Device Development and Regulatory Excellence
Accelerating time to market, improving safety, and enabling innovation for pharmaceutical and medtech teams, whilst enhancing outcomes and enriching the quality of life for their users.
Cambridge, UK
Leeds, UK
Utrecht, Netherlands
Boston, Massachusetts
Chadds Ford, Pennsylvania (HQ)
San Jose, California
WHERE WE ARE
Navigating the Global Landscape with Local Expertise
Strategically located teams, well-versed in national regulations, cultural nuances, and international best practices, are equipped to meet diverse client needs and navigate the complexities of the global medical device landscape.
Cambridge, UK
Leeds, UK
Utrecht, Netherlands
Boston, Massachusetts
Chadds Ford, Pennsylvania (HQ)
San Jose, California
WHERE WE ARE
Navigating the Global Landscape with Local Expertise
Strategically located teams, well-versed in national regulations, cultural nuances, and international best practices, are equipped to meet diverse client needs and navigate the complexities of the global medical device landscape.
Cambridge, UK
Leeds, UK
Utrecht, Netherlands
Boston, Massachusetts
Chadds Ford, Pennsylvania (HQ)
San Jose, California
WHERE WE ARE
Navigating the Global Landscape with Local Expertise
Strategically located teams, well-versed in national regulations, cultural nuances, and international best practices, are equipped to meet diverse client needs and navigate the complexities of the global medical device landscape.
WHO WE ARE
Multidisciplinary Team of Experts
With diverse backgrounds in engineering and science, that include human factors, industrial, biomedical, psychology, and quality engineering, our team can rapidly onboard to your novel technology and company’s quality system to contribute valuable input to your program.
WHO WE ARE
Multidisciplinary Team of Experts
With diverse backgrounds in engineering and science, that include human factors, industrial, biomedical, psychology, and quality engineering, our team can rapidly onboard to your novel technology and company’s quality system to contribute valuable input to your program.
WHO WE ARE
Multidisciplinary Team of Experts
With diverse backgrounds in engineering and science, that include human factors, industrial, biomedical, psychology, and quality engineering, our team can rapidly onboard to your novel technology and company’s quality system to contribute valuable input to your program.
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.