luda, Author at R.S NESS

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

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