Resources

Connected devices often feature complex system architectures with multiple components and subsystems, frequently developed by different teams. This session will highlight common pitfalls encountered during the development of connected devices—issues...

So you think you’ve got a connected medical device? Medical Device Regulators do not approve good ideas, they approve fully developed medical devices. This means that a working prototype and...

The new US Presidential Administration could bring significant impact on MedTech and pharmaceutical regulations for manufacturers and product developers. Join our expert panel of scientists and FDA consultants as they...

This presentation provides a comprehensive overview of the FDA’s medical device pre-submission process, a critical step for manufacturers seeking to efficiently bring safe and effective devices to market. This session...

The Sterilization Road Map to Authorization in the EU Sterile Medical Devices must follow the regulations and standards for CE marking that went into effect May 2021. Medical devices being...

The pandemic created a backlog of delayed inspections in its wake, and regulatory bodies are prepared to hire additional employees and significantly increase the rate of inspections. That means an...