How to establish DHR
CHALLENGE: Following an audit conducted in a Medical Device Company, it became apparent that the Device History Record (DHR) release
CHALLENGE: Following an audit conducted in a Medical Device Company, it became apparent that the Device History Record (DHR) release
Commercializing medical technology is challenging, often requiring 10 – 20 years just to bring new ideas to market. There is
You have a medical device product that has been on the market for a short period of time with FDA
NanoSono nanomaterials technology transforms almost any medical device, fabric, filters, or any type of surfaces into an antibacterial surface and
Challenge: In order to obtain CE mark certification for an innovative medical device, the Medical Device company was required to
General Manager Of RS Ness America
Following the acquisition of Israeli Medical Device company by global corporation, a gap assessment was performed, resulting in identifying gaps
Senior Project Manager and Validation SME
The compliance requirements of EU-GMP are numerous, and many projects don’t meet their deadline. RS NESS supported a company in
Director or Regulatory Affairs