Distribution led by an engineer.
OnyxDerma is building a focused channel for RF, ultrasound and HIFU devices. The founder, a medical engineer, has hands-on experience in the quality assurance and maintenance of medical devices.
What we bring
What we bring
Engineering evaluation
We understand your device at the level of physics and tissue interaction, and we explain it to doctors in their language.
Four working languages
We speak with clinics in Hebrew, Arabic and English, and with manufacturers in German and English.
Regulatory preparation
Hands-on experience with FDA and ISO 13485 documentation: DHR, DMR, CAPA. We prepare the file for the Ministry of Health medical device register (AMAR), submitted through a local registration holder.
Training and after-sales
Staff training, protocols and first-line technical support for every installed device.
What we look for
- RF, ultrasound and HIFU devices with CE marking or FDA clearance
- Manufacturers without an active local representative
- A partner who invests in training and clinical evidence
How the first conversation works
A short call about your device and your plans for the region
We share our market view and a proposed entry plan
A pilot with one or two clinics, then a distribution agreement
Start the conversation
What happens next
We name a manufacturer on this site only once an agreement is signed.