Transparency as
differentiation.

Every compliance detail, published. The move no bad actor in this industry would dare make.

The laws we operate under.

FDA 21 CFR Part 1271

HCT/P establishment registration requirements. Donor eligibility, cGTP, and establishment registration.

Anti-Kickback Statute (42 U.S.C. § 1320a-7b)

Prohibits offering, paying, soliciting, or receiving anything of value to induce referrals. Dermalynx uses fixed-fee, non-volume-contingent compensation.

False Claims Act (31 U.S.C. § 3729)

Liability for knowingly submitting false claims to government programs. Our documentation practices ensure accuracy.

Stark Law (42 U.S.C. § 1395nn)

Physician self-referral prohibition. Dermalynx's commercial structure avoids prohibited financial relationships.

Built before the first sale.

Compliance Officer

Designated officer with authority to implement and enforce compliance policies.

Annual Training

All personnel complete AKS and compliance training annually. Documented and tracked.

OIG Screening

Monthly screening of all personnel and customers against the OIG List of Excluded Individuals and Entities.

Customer Certifications

Pre-onboarding compliance certification required. Quarterly due diligence thereafter.

Compliance Hotline

Confidential reporting mechanism for compliance concerns.

Monitoring & Auditing

Monthly compliance dashboard. Quarterly internal audits. Annual program review.

Read our policies.

No email gate. No form. Direct downloads.

For compliance inquiries: [email protected]