Overview
ClariMed provides specialized consulting for the medical device industry, offering human-centered design, engineering, and regulatory support on a fee-for-service basis. Its services cover the full product lifecycle—from concept to post-market surveillance—guided by human factors engineering, usability testing, and regulatory affairs expertise to help devices meet safety and usability standards. Unlike companies that offer narrow services, ClariMed combines design and engineering with regulatory strategy across global health authorities to streamline development and market access. The company’s goal is to accelerate the product development process while ensuring devices are safe, usable, and compliant for patients and healthcare professionals.
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Simplify's take
What believers are saying
- ClariMed was named to the 2025 Inc. 5000 list for fast revenue growth.
- CEO Kelley Kendle's November 2026 award shortlist strengthens sales credibility with MedTech buyers.
- New Cambridge and Atlanta sites expand recruiting, client access, and participant diversity.
What critics are saying
- ClariMed still sells services; AI tools and in-house medtech teams compress consulting margins.
- The August 2025 We Are Human integration risks culture clashes and duplicated lab costs.
- If FDA and MHRA workflows digitize, ClariMed becomes a commoditized niche and disappears.
What makes ClariMed unique
- ClariMed combines human factors, regulatory affairs, and design development under one ISO 13485 scope.
- We Are Human added Atlanta usability lab and IEC-62366 expertise in August 2025.
- Offices in Chadds Ford, Cambridge, Leeds, San Jose, and Atlanta serve transatlantic clients.
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