Preparing your QMS for the EU MDR
Current MDR Status Medical Device companies selling devices to the EU are already preparing to re-certify their products (all classes)
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Medical Device
How to establish DHR
CHALLENGE: Following an audit conducted in a Medical Device Company, it became apparent that the Device History Record (DHR) release
Medical Device Roadmap from Idea to Market
Commercializing medical technology is challenging, often requiring 10 – 20 years just to bring new ideas to market. There is
Your Packaging Validation Guideline
You have a medical device product that has been on the market for a short period of time with FDA
The Nanosono journey- from idea to ISO13485 Certification
NanoSono nanomaterials technology transforms almost any medical device, fabric, filters, or any type of surfaces into an antibacterial surface and
Validation of Medical Device manufacturing line for getting the European CE mark certification.
Challenge: In order to obtain CE mark certification for an innovative medical device, the Medical Device company was required to