Expert Insights

Explore practical guidance to help medical technology teams reduce risk, make informed decisions, and bring life-changing products to patients faster.
All TopicsNewsMedical DevicesRegulationsSoftwareDocumentsQualityEUEngineeringPost-MarketRisk ManagementDe NovoEuropean UnionGlobalHuman FactorsQuality SystemsRisk AnalysisSterilizationUK
Comparing UK MHRA Standalone Software and IMDRF Software as Medical Device Guidance Documents
digital overlay coming from laptop
Medical Devices

Comparing UK MHRA Standalone Software and IMDRF Software as Medical Device Guidance Documents

June 22, 2023 2 min read
MHRA: Standalone Software and Apps
person using computer with abstract technology graphics over top
Medical Devices

MHRA: Standalone Software and Apps

June 8, 2023 4 min read
Advancing Healthcare Innovation: FDA Explores AI/ML in Drug Development and Devices
hand holding tablet with abstract brain graphic floating over top
Medical Devices

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
News

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
News

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
Medical Devices

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
News

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
News

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
Risk Management

Team NB Position Paper Submission of Technical Documentation Highlights

March 16, 2023 5 min read
34567

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.