UserWise, a ClariMed Company
UserWise, a ClariMed Company, provides human factors engineering, usability testing, and FDA regulatory compliance consulting for medical device manufacturers and pharmaceutical companies developing combination products, now operating as part of ClariMed's integrated MedTech services platform across five global offices.
- Company typePrivate
- Founded2023
- HeadquartersChadds Ford, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What UserWise, a ClariMed Company does
UserWise, LLC operates as a wholly-owned subsidiary of ClariMed, Inc., providing human factors engineering, usability testing, and FDA regulatory compliance consulting services for medical device and pharmaceutical companies. Founded in 2015 in San Jose and acquired by ClariMed in January 2023 as the platform's foundational asset, UserWise is now fully integrated into ClariMed's global usability and market insights practice alongside Harvey Medical (acquired February 2023) and We Are Human (acquired August 2025). The firm delivers a five-part Usability Engineering Process spanning user research, use-related risk analysis, iterative prototyping and usability testing, usability validation, and human factors regulatory submission support, aligned to FDA, IEC 62366-1, ISO 14971, and EU MDR requirements.
Service delivery is anchored in dedicated study facilities equipped with one-way mirrors and simulated use environments (home use, clinical, surgical) located in San Jose (~10,000 sq ft), Cambridge UK (~10,000 sq ft), and Atlanta, supported by an in-house participant recruitment team with connections to disease-specific support groups. Engagement models include project-based consulting, embedded resource deployments, monthly retainer arrangements, and end-to-end service partnerships, priced on a quote basis rather than fixed rate cards. The customer base targets medical device manufacturers and pharmaceutical companies developing drug delivery devices and combination products, with documented engagements across fertility (Béa Fertility), cardiac implants, migraine inhalers, biosimilar prefilled syringes, oncology/neurology implants, and HIV treatment devices.
ClariMed (parent) was formed in partnership with NaviMed Capital, a Washington D.C. healthcare-focused private equity firm with over $400M in assets under management, and has grown from 20 to 70 consultants across five global offices (Chadds Ford HQ, Boston, San Jose, Atlanta, Cambridge UK, Leeds) since January 2023. The platform has expanded service lines into Quality Assurance Services (QMS, Document Control, Design Control, Audits), Digital Health Services (software development, UX/UI, cloud, cybersecurity), and Strategy & Advisory. Achieved ISO 13485:2016 certification through BSI in July 2025 and named to the Inc. 5000 list in 2025. Revenue is not publicly disclosed.
UserWise, a ClariMed Company firmographics
Firmographics- Name
- UserWise, a ClariMed Company
- Legal name
- ClariMed, Inc.
- Website
- https://clarimed.com
- Company type
- Private
- Founded year
- 2023
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- UserWise, a ClariMed Company, provides human factors engineering, usability testing, and FDA regulatory compliance consulting for medical device manufacturers and pharmaceutical companies developing combination products, now operating as part of ClariMed's integrated MedTech services platform across five global offices.
- Ownership category
- akta.pro rank
UserWise, a ClariMed Company industry classification
Industry- Product category
- Medical Device Human Factors Engineering Consulting
- NAICS
- Other Scientific and Technical Consulting Services (541690), Scientific Research and Development Services (5417), Custom Computer Programming Services (541511), Industrial Design Services (541420), Testing Laboratories and Services (541380)
- SIC
- Services-Testing Laboratories (8734), Services-Commercial Physical & Biological Research (8731), Services-Computer Programming, Data Processing, Etc. (7370)
- akta.pro primary industry
- Pharmacovigilance Quality & Compliance (PV audits, QPPV support, PSMF) (HLAGAKAH)
- akta.pro secondary industries
- DTx/SaMD Evidence, Outcomes & Real-World Data (RWE) Platforms (HLACANAM), SaMD – Digital Biomarkers & Algorithmic Endpoints (HLACANAF), eConsent & Digital Identity for Trials (HLACAOAE)
Keywords
Where UserWise, a ClariMed Company is headquartered
LocationHeadquarters
- HQ city
- Chadds Ford
- HQ country
- United States
- HQ region
- North America
Offices6 records
Markets served
UserWise, a ClariMed Company business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure
Revenue model
- Human Factors & Usability Consulting Services: Professional services revenue generated through consulting engagements with medical device and pharmaceutical companies. Services include human factors research, usability testing, regulatory support, and strategy advisory. Engagement models range from project-based work to retainer arrangements and embedded resource deployments.
- Study Facility & Testing Services: Revenue from conducting usability studies in state-of-the-art facilities equipped with one-way mirrors, simulated use environments (home use, clinical, surgical), and observation capabilities.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Project-Based Consulting |
| Other | Multi-year contract | Embedded Resources |
| Subscription | Monthly | Retainer Model |
| Other | Multi-year contract | End-to-End Services |
Go-to-market motion1 record
Distribution channels1 record
Marketing channels6 records
UserWise, a ClariMed Company product offering
Product offeringCore offering
UserWise, a ClariMed Company, provides human factors engineering and usability testing services for medical device, combination product, and IVD development. Services span formative evaluations, usability validation testing, use-related risk analysis (URRA), market insights research, and regulatory submission support aligned with FDA, IEC 62366-1, and MDR requirements, delivered through project-based consulting, embedded resources, retainer arrangements, and end-to-end engagements from state-of-the-art usability study facilities in San Jose.
Differentiator
Problem solved
Functional benefit
Brands
- ClariMed University: Educational platform offering professional development courses in medical device human factors engineering and regulatory compliance.
Products and services
- Human Factors & Usability Studies End-to-end human factors and usability services for medical devices, combination products, and IVDs, including user research, formative usability testing, validation (summative) testing, use-related risk analysis (URRA), and human factors regulatory submission support aligned with FDA, IEC 62366-1, ISO 14971, and EU MDR requirements. Target buyers are medical device and pharmaceutical manufacturers.
- Quality Assurance Services Comprehensive medical device quality assurance services including quality management system (QMS) implementation, document control, design control, audits, risk management, production control, and complaint management for medical device manufacturers.
- Digital Health Services Digital solutions for medical devices and pharmaceutical companies, including UI/UX design for medical interfaces, cybersecurity solutions, AI/ML, and cloud connectivity support for regulated medical products.
- Strategy & Advisory Services Strategy and advisory services guiding medical device and pharmaceutical companies through complex regulatory landscapes (FDA, EU MDR) and user-centered innovation, including strategy design and regulatory readiness planning.
- Market Insights Research Market insights research uncovering valuable market trends, customer preferences, and competitive landscapes, including online qualitative interviews and in-depth user research, to inform medical device strategy and product development.
Quantifiable outcome
- 40% reduction in document approval and release timeline for auto-injector client
- +3 more outcomes
Companies that use UserWise, a ClariMed Company
Customer profileNamed customers6 records
Segments2 records
Ideal customer profiles3 records
UserWise, a ClariMed Company technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
UserWise, a ClariMed Company partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- We Are HumancoreClariMed acquired We Are Human, an Atlanta-based usability lab and expert team led by Principal Annmarie Nicolson. The acquisition expanded ClariMed's presence in the Southeast US market and added capabilities in human factors research and usability testing.
Scale indicators4 records
Recent moves12 records
Expansion highlights6 records
UserWise, a ClariMed Company competitors and assessment
Company assessmentDirect peers
- Ximedica: Medical device development services firm combining human factors, industrial design, and engineering. Overlapping client base of medtech manufacturers needing integrated HF and product development support.
- Insight Product Development: Medical device and life sciences product development firm providing human factors research, usability testing, and design services. Direct overlap with ClariMed's integrated services model.
- Emergo by UL: Global medical device regulatory, quality, and human factors consulting practice owned by UL. Offers HF validation, usability engineering, and FDA/MDR submission services to the same medtech and pharma client base.
- Bresslergroup: Medical device and consumer health product development consultancy with integrated human factors, design, and engineering teams. Competes for the same HF-driven medtech RFPs.
- Core Human Factors: Specialist human factors engineering consultancy focused on medical device and combination product usability, validation, and FDA submission support. Closest comparable in scale and service mix to UserWise's pre-acquisition offering.
- RKS Design: Design and human factors consultancy with deep medical device and consumer health practice. Comparable HF validation, user research, and regulatory submission support offerings.
Broad incumbents
- BSI (British Standards Institution): Standards body and certification/consulting firm providing ISO 13485 certification and medtech regulatory services. ClariMed's ISO 13485:2016 certification is through BSI; BSI also competes in adjacent consulting.
- TÜV SÜD: Global testing, inspection, and certification organization offering medical device regulatory and HF consulting services. Broader portfolio than ClariMed but competes on regulatory submission support.
- PA Consulting: Global consulting firm with regulated products and medical device practices including human factors and regulatory services. Competes for large multinational medtech transformation and product development engagements.
- NAMSA: Larger medical device-focused CRO providing regulatory, clinical, and laboratory testing services. Overlaps with ClariMed on HF/quality services for medtech manufacturers but is much broader in scope.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks7 records
Key highlights8 records
Customer concentration
UserWise, a ClariMed Company social profiles
Digital presenceUserWise, a ClariMed Company financial estimates
Financial estimateRevenue estimate
Valuation estimate
UserWise, a ClariMed Company leadership team
Management profileNumber of profiles
Profiles10 records
UserWise, a ClariMed Company subsidiaries and ownership
Company hierarchySubsidiaries3 records
UserWise, a ClariMed Company funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
UserWise, a ClariMed Company M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about UserWise, a ClariMed Company
What does UserWise, a ClariMed Company do?
UserWise, a ClariMed Company, provides human factors engineering and usability testing services for medical device, combination product, and IVD development. Services span formative evaluations, usability validation testing, use-related risk analysis (URRA), market insights research, and regulatory submission support aligned with FDA, IEC 62366-1, and MDR requirements, delivered through project-based consulting, embedded resources, retainer arrangements, and end-to-end engagements from state-of-the-art usability study facilities in San Jose.
Is UserWise, a ClariMed Company a public or private company?
UserWise, a ClariMed Company is a private company. It is classified as private equity controlled and is currently operating.
When was UserWise, a ClariMed Company founded?
UserWise, a ClariMed Company was founded in 2023. It employs 11 to 50 people.
Where is UserWise, a ClariMed Company based?
UserWise, a ClariMed Company is headquartered in Chadds Ford, United States, in the North America region.
How does UserWise, a ClariMed Company make money?
Two revenue lines are on record. Human Factors & Usability Consulting Services are the primary driver. The others are study Facility & Testing Services.
Who are UserWise, a ClariMed Company's main competitors?
Direct peers on record are Ximedica, Insight Product Development, Emergo by UL, Bresslergroup, Core Human Factors and RKS Design. Broad incumbents are BSI (British Standards Institution), TÜV SÜD, PA Consulting and NAMSA.
Does UserWise, a ClariMed Company have an API?
No public API is recorded for UserWise, a ClariMed Company.
What industry is UserWise, a ClariMed Company in?
UserWise, a ClariMed Company's product category is Medical Device Human Factors Engineering Consulting. Its primary akta.pro industry code is HLAGAKAH, Pharmacovigilance Quality & Compliance (PV audits, QPPV support, PSMF), with a secondary code of HLACANAM, DTx/SaMD Evidence, Outcomes & Real-World Data (RWE) Platforms. Its NAICS code is 541690 and its SIC code is 8734.