UserWise, a ClariMed Company
ClariMed is a global leader in human-centered medical device development, regulatory services, and innovative research facilities. They focus on putting the user at the core of product design, ensuring safety, usability, and efficacy through iterative, quality-by-design approaches. With a multidisciplinary team and strategic locations across the US and UK, ClariMed advances medical innovation, expands its global presence, and maintains a strong commitment to excellence and employee satisfaction.
Industries
Nr. of Employees
small (1-50)
UserWise, a ClariMed Company
San Jose, California, United States, North America
Products
Medical Device Development & Regulatory Services
UserWise, a ClariMed Company, offers services that integrate human factors throughout the product lifecycle, providing a comprehensive approach from concept to commercialization for medical product innovators.
Medical Device Development & Regulatory Services
UserWise, a ClariMed Company, offers services that integrate human factors throughout the medical product lifecycle, providing a comprehensive path from concept to commercialization.
Medical Device Development & Regulatory Services
UserWise, a ClariMed Company, offers services that integrate human factors throughout the product lifecycle, providing a comprehensive approach from concept to commercialization for medical product innovators.
Medical Device Development & Regulatory Services
UserWise, a ClariMed Company, offers services that integrate human factors throughout the medical product lifecycle, providing a comprehensive path from concept to commercialization.
Services
Human Factors & Usability Studies
End-to-end human factors services including formative research, protocol development, moderated testing, usability validation, data analysis and regulatory-aligned documentation.
Quality Services (QMS implementation and QA)
Implementation and optimization of quality management systems, document control, audits, design validation support and risk management aligned to ISO 13485 and medical device regulations.
Digital Solutions (Regulated software and digital health)
Design and development services for regulated medical software and digital health products including UI/UX design, secure cloud/mobile implementations, AI/ML integration and cybersecurity considerations.
Strategy & Advisory
Regulatory and product strategy services including submission planning, human factors strategy, market strategy, and guidance on international regulatory pathways and commercialization.
Simulated-use Research Facilities
On-site simulated-use testing facilities and observation suites that replicate clinical, home and surgical environments for controlled human factors and usability studies.
Study Operations & Recruitment
Operational support for study logistics including participant recruitment, screening, scheduling, on-site coordination and facility management for usability and human factors studies.
Human Factors & Usability Studies
End-to-end human factors services including formative research, protocol development, moderated testing, usability validation, data analysis and regulatory-aligned documentation.
Quality Services (QMS implementation and QA)
Implementation and optimization of quality management systems, document control, audits, design validation support and risk management aligned to ISO 13485 and medical device regulations.
Digital Solutions (Regulated software and digital health)
Design and development services for regulated medical software and digital health products including UI/UX design, secure cloud/mobile implementations, AI/ML integration and cybersecurity considerations.
Strategy & Advisory
Regulatory and product strategy services including submission planning, human factors strategy, market strategy, and guidance on international regulatory pathways and commercialization.
Simulated-use Research Facilities
On-site simulated-use testing facilities and observation suites that replicate clinical, home and surgical environments for controlled human factors and usability studies.
Study Operations & Recruitment
Operational support for study logistics including participant recruitment, screening, scheduling, on-site coordination and facility management for usability and human factors studies.
Expertise Areas
- Clinical human factors and usability research
- Human-centered design and UX for regulated devices
- Regulatory strategy and submission planning (FDA & international)
- Quality management systems and ISO 13485 compliance
Key Technologies
- Human factors engineering methods
- Usability testing and validation protocols
- Human factors and software standards (IEC 62366, AAMI HE75, IEC 62304)
- UI/UX design for regulated products