Medical device manufacturers must ensure the biosafety of their medical implant products to comply with relevant regulations. Medical implants have intimate contact with the human body for durations lasting a few hours to permanently. As such, they are subject to...
The FDA has just recognized the recently updated ISO 10993 Part 17 standard covering the toxicological risk assessment of medical device constituents. Apart from a few exceptions, the FDA recognized the standard for its relevance and scientific and technical merit....
The ISO 10993 standard series covers the biological evaluation of medical devices. Part 17 of this series addresses the toxicological risk of chemical constituents resulting from the chemical characterization of medical devices. In its first major revision in 20...
We are very proud that our CTO, Carsten Senholt, has a central role in the international writing group developing ISO 10993-17, which was recently submitted as a final draft. The ISO 10993 series is a suite of standards covering the biological evaluation of medical...
Ensuring the biosafety of your medical implants is necessary for getting them in compliance with relevant regulations. Medical implants come into intimate contact with the human body for periods lasting from a few hours to permanently. As such, they are subject to...
Surfaces are everywhere, and we constantly come into contact with them. To live in this world means touching surfaces, so we rarely give it any thought. But, the things we manufacture, the things we wear on or have implanted in our bodies that we come into contact...
