Successful integration requires a rethinking around the role of data science in product design and lifecycle management.
A rapidly aging population, along with economic growth and rising industrialization, is driving a big increase of the disease.
The first critical step in being able to feel confident about your clinical evaluation reports (CERs) is to ensure you know exactly what they entail.
A brief look at the science behind the test strip.
The agency’s latest announcements are indicative of its focus on risk reduction while promoting innovation.
Learn about the implications of changes to ISO 10993-1 and the introduction of the MDR, stages of pre-clinical device testing, why chemical characterization is more important than ever before, and how device manufacturers can begin assembling the right team of testing experts to ensure their products are safe and ready for market.
Advanced manufacturing technology in the here and now.
With the evolution of medical electric technology, EMC concerns are crucial.
Getting your requirements right early in the development process can help avoid problems during final manufacturing.
An explanation of these principles and the actions that must be addressed in compliance with 21 CFR 820, ISO 13485 and the EU MDR.