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
Services
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 management system implementation, document control, design validation planning, strategic quality planning and internal audits tailored to regulatory requirements.
UX/UI design, cybersecurity, and regulated software development services for connected medical devices and digital health products, including cloud connectivity and AI/ML integration.
Regulatory and product strategy services including submission planning, human factors strategy, and market entry advice for international markets.
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.
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 management system implementation, document control, design validation planning, strategic quality planning and internal audits tailored to regulatory requirements.
UX/UI design, cybersecurity, and regulated software development services for connected medical devices and digital health products, including cloud connectivity and AI/ML integration.
Regulatory and product strategy services including submission planning, human factors strategy, and market entry advice for international markets.
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