Expert Insights | News

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
The FDA isn’t experimenting with AI anymore — it’s operationalizing it.
AI robot helping human
News

The FDA isn’t experimenting with AI anymore — it’s operationalizing it.

December 17, 2025 1 min read
Strengthening Medical Device Security in the Age of AI Threats
abstract globe graphic with AI over top of it
News

Strengthening Medical Device Security in the Age of AI Threats

August 12, 2025 1 min read
High-Risk IVDs Drive Immediate Transition to IVDR
blue alarm clock disintegrating
Regulations

High-Risk IVDs Drive Immediate Transition to IVDR

March 11, 2025 3 min read
Top 5 Upcoming FDA and EU Regulations – What to Know for 2025
gears representing regulations and compliance
Regulations

Top 5 Upcoming FDA and EU Regulations – What to Know for 2025

January 13, 2025 4 min read
Unlocking Success in Regulatory Compliance: POLARISᴬᴿ’s Journey to FDA 510(k) Clearance with MEDIcept Consulting Experts
case study
Software

Unlocking Success in Regulatory Compliance: POLARISᴬᴿ’s Journey to FDA 510(k) Clearance with MEDIcept Consulting Experts

November 22, 2024 1 min read
Navigating FDA Clearance: Sira Medical’s Success Story with Medicept
computer screen with case study graphic
Software

Navigating FDA Clearance: Sira Medical’s Success Story with Medicept

November 18, 2024 1 min read
Cybersecurity Post-Market Surveillance
cube with lock icon rising above the others
News

Cybersecurity Post-Market Surveillance

October 28, 2024 3 min read
Cybersecurity Risk Control
red graphic featuring a digital padlock
Risk Analysis

Cybersecurity Risk Control

October 24, 2024 3 min read
Threat Modeling for Medical Devices
graphic of a lock representing security
Software

Threat Modeling for Medical Devices

October 21, 2024 2 min read
12345

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.