Areas of Expertise

Dermatologic

Wound healing devices must prove they speed closure without creating unacceptable scarring. Injectable fillers face a tougher test. Your filler must stay where you put it, maintain volume for months, and integrate without causing lumps or migration.

Our Dermatologic Expertise

Your aesthetic energy device requires demonstrating tissue response without excessive inflammation. Each device type requires specialized validation approaches. Our wound models and biocompatibility assessment capabilities replicate the conditions your device will face clinically.

Our standardized outcome measures and regulatory success provide the biocompatibility and effectiveness data FDA reviewers expect. We understand dermal tissue healing, aesthetic applications, and what makes dermatologic testing different.

Complete Dermatologic Capabilities

Wound Healing

Here is the wound management challenge. Your device must prove closure effectiveness while minimizing scar formation. Healing quality matters as much as healing speed. We evaluate device performance using standardized wound models that replicate acute surgical incisions and chronic ulcer conditions. We track wound area reduction through planimetric imaging and characterize granulation tissue quality, collagen deposition, and epithelialization. Our GLP protocols follow ISO 10993 standards supporting both 510(k) and PMA pathways for negative pressure therapy systems, advanced dressings, and tissue scaffolds.

Aesthetics

Dermal fillers face unique validation challenges. Your product must integrate into tissue without migrating and maintain volume augmentation throughout claimed duration while minimizing inflammatory response. We evaluate filler performance through injection technique standardization and measure volumetric persistence and tissue integration. Advanced imaging quantifies filler distribution and volume retention while histopathology assesses tissue incorporation quality. Our protocols address hyaluronic acid, calcium hydroxylapatite, and permanent filler materials following ISO 10993 standards and FDA aesthetic device guidance.

Ready to Start Your Dermatological Program?

Let's discuss your device and what regulatory pathway makes sense. We'll design a validation strategy that addresses both biocompatibility and aesthetic or healing effectiveness.

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