HARVEY MEDICAL CONSULTING LIMITED
ClariMed is dedicated to human-centered medical device, combination product, and IVD development. They focus on innovation, collaboration, and excellence in human-centered medical device development and regulatory services, aiming to revolutionize healthcare through innovative solutions and a culture of safety, efficacy, and user satisfaction.
Industries
Nr. of Employees
small (1-50)
HARVEY MEDICAL CONSULTING LIMITED
Cambridge, Cambridgeshire, United Kingdom, Europe
Services
Human Factors & Usability Studies
Formative and validation usability studies, user needs assessment, protocol development, moderation, data analysis, and HF documentation for regulatory submissions; operation of simulated-use study facilities where applicable.
Quality Services
Quality management system implementation, document control, design validation planning, strategic quality planning and internal audits tailored to regulatory requirements.
Digital Solutions
UX/UI design, cybersecurity, and regulated software development services for connected medical devices and digital health products, including cloud connectivity and AI/ML integration.
Strategy & Advisory
Regulatory and product strategy services including submission planning, human factors strategy, and market entry advice for international markets.
Training & Education (Human Factors)
Structured training programs, seminars, and workshops on human factors, usability testing, and related best practices delivered through an online learning platform and in-person sessions.
Human Factors & Usability Studies
Formative and validation usability studies, user needs assessment, protocol development, moderation, data analysis, and HF documentation for regulatory submissions; operation of simulated-use study facilities where applicable.
Quality Services
Quality management system implementation, document control, design validation planning, strategic quality planning and internal audits tailored to regulatory requirements.
Digital Solutions
UX/UI design, cybersecurity, and regulated software development services for connected medical devices and digital health products, including cloud connectivity and AI/ML integration.
Strategy & Advisory
Regulatory and product strategy services including submission planning, human factors strategy, and market entry advice for international markets.
Training & Education (Human Factors)
Structured training programs, seminars, and workshops on human factors, usability testing, and related best practices delivered through an online learning platform and in-person sessions.
Expertise Areas
- Human factors engineering
- Usability testing and validation
- Regulatory strategy and international submissions
- Quality management systems and QA
Key Technologies
- Usability testing methodologies (formative and summative)
- Human factors engineering methods
- UX/UI design for medical devices
- Medical device cybersecurity practices