Whether you are a pharmaceutical or medical device manufacturer, you need to comply with several layers of guidelines and regulations to bring your products to market and keep them there. Having suppliers you can trust is crucial to your ability to concentrate on...
Pharmaceutical and medical device manufacturers and materials suppliers must ensure their products are not shedding harmful particles. Unexpected particulate findings during production are a risk that all manufacturers face. Sudden, unexpected findings of particulate...
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....
Do you use silicone in the medical devices you produce? If so, you need to be aware that the European Chemicals Agency (ECHA) can now classify silicone oligomers, specifically D4, D5, and D6 siloxanes, as Persistent Bioaccumulative and Toxic substances (PBT), Very...
Medical device manufacturers need to screen the materials used in their products. Proper biosafety and sourcing require having full transparency about the physical and chemical information associated with the materials throughout the supply chain. Knowing what is in...
Pharmaceutical manufacturers need to know whether their products contain nitrosamine impurities and, if so, whether they are below the thresholds established by various regulatory agencies. Nitrosamines are highly toxic compounds, with some considered even more...
