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.
A guide to what to expect during your certification audit and how to prepare.
The market is projected to hit nearly $4.2 billion by 2025.
A review of the status and prospects of key markets in India, Thailand, Indonesia and Vietnam.
Regional demand for more equipment and sophisticated treatment is expected to grow.
Research and development activities to find potential treatments using next generation sequencing for various fatal conditions including melanoma, epilepsy, antibody deficiency, and other diseases have gained traction. In April, FDA finalized two guidance documents to speed up development of NGS-based tests.