About us

Regulatory and Quality Assurance

At Dr. Korman Laboratories, compliance and quality are part of every stage of the product lifecycle, from raw material selection to post-market surveillance. With registrations in over 50 countries, our in-house Regulatory Affairs team has extensive experience navigating diverse regulatory frameworks and bringing products to new markets.

Quality Certifications

ISO 13485:2016 and EN ISO 13485:2016

Certified by BSI

Scope: “Design, development, manufacture, primary and secondary packaging, and distribution of sterile medical volume filling products for aesthetics treatments.”

MDSAP

Medical Device Single Audit Program, certified by BSI

Scope: “Design, manufacture, packaging and distribution of sterile medical volume filling products for aesthetics treatments.”

ANVISA Good Manufacturing Practices Certificate

Brazil

ISO 22716:2007

Good Manufacturing Practices for cosmetic products, certified by IQC

CE-mark (Medical Device Directive 93/42 ECC)

Extended under transitional provisions (2023/607) until 31.12.2027

Product availability, regulatory status and approved intended use vary by market. Contact us for the regulatory status in your country.