Meeting Regulatory Compliance Requirements in Today’s Global Market

Medical device manufacturers and their supply chains must bring their products to market quickly. This while facing new technological challenges, global competition and the need to limit risks.

Medical devices with electrical, mechanical and software components introduce even more obstacles, as companies strive to navigate the ever-changing landscape of regulations. Including FDA (for example FDA 21 CFR part 11 and part 820), ISO (for example 13485, 14791), UL, OSHA and environmental compliance (e.g. RoHS, REACH, conflict minerals).