We Build &Implement a worthy Quality Management system during the process of developing and manufacturing medical devices.
Reviews & Audits
- we preform Reviews through out the implantation process of the quality system for CE / ISO:13485.
- We preform periodic internal Audits.
- We will make an extensive and detailed Audit report that will include findings and guide lines about how to correct them.
- We do Sub-contractor and supplier Audits for assessment and certification purposes.
We specialize in QA/RA for Medical Devices.
We escort Businesses from the idea stage to the manifestation of the idea and getting certified by ISO 13485, CE according to MDR 2017/745, FDA & more
IRH - Israeli Registration Holder.
We act as an "in - house" IRH for Over seas Medical Device companies and we can Register your device to the Medical Device Division (known as AMAR) of the Israeli Ministry of Health.
We also apply Medical devices for Israeli companies to the Medical Device Division (known as AMAR) of the Israeli Ministry of Health in order to register their Medical Device.