Expert Insights

Explore practical guidance to help medical technology teams reduce risk, make informed decisions, and bring life-changing products to patients faster.
Advancing Healthcare Innovation: FDA Explores AI/ML in Drug Development and Devices
hand holding tablet with abstract brain graphic floating over top

Advancing Healthcare Innovation: FDA Explores AI/ML in Drug Development and Devices

May 24, 2023 5 min read
FDA’s New Clinical Trial Guidance Allows you to Streamline!
compass pointing north to guidance

FDA’s New Clinical Trial Guidance Allows you to Streamline!

May 4, 2023 3 min read
FDA “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry” Clinical Insight Paper
game changer

FDA “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry” Clinical Insight Paper

April 13, 2023 5 min read
Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices Under Section 524B of the FD&C Act
typing at keyboard with graphic overlay

Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices Under Section 524B of the FD&C Act

April 5, 2023 2 min read
Health Industry Cybersecurity: Managing Legacy Technology Security (HIC-MaLTS)
lock icon on part of a microchip

Health Industry Cybersecurity: Managing Legacy Technology Security (HIC-MaLTS)

March 30, 2023 4 min read
A Focus on the Challenges with Utilizing Remote Monitoring in Patient Healthcare
illustration representing the future of healthcare

A Focus on the Challenges with Utilizing Remote Monitoring in Patient Healthcare

March 28, 2023 5 min read
Team NB Position Paper Submission of Technical Documentation Highlights
man pointing to document icon

Team NB Position Paper Submission of Technical Documentation Highlights

March 16, 2023 5 min read
FDA Seeking Sources for Medical Device Active Surveillance System – Understanding FDA’s Request
graphic of connecting people

FDA Seeking Sources for Medical Device Active Surveillance System – Understanding FDA’s Request

March 10, 2023 4 min read
New Brazil Regulation for Medical Devices Now In Effect – Steps to Take
Brazil flag

New Brazil Regulation for Medical Devices Now In Effect – Steps to Take

March 9, 2023 3 min read

Patients Are Waiting.

Every submission, study, inspection, and commercialization decision moves a patient closer to the technology they're waiting for. Partner with Medicept to navigate every milestone with clarity, continuity, and confidence.