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Regulating Generative AI Medical Devices: A Medicept Expert Roundtable
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Regulations

Regulating Generative AI Medical Devices: A Medicept Expert Roundtable

October 13, 2026 11 min read
EUDAMED Is in Force. How Is Your Data Holding Up?
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UK

EUDAMED Is in Force. How Is Your Data Holding Up?

October 2, 2026 7 min read
QMSR at Five Months: What FDA Inspections Now Expect
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QMSR at Five Months: What FDA Inspections Now Expect

August 25, 2026 7 min read
510k vs. De Novo vs. PMA: Which FDA Pathway Is Right for Your Device?
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510k vs. De Novo vs. PMA: Which FDA Pathway Is Right for Your Device?

August 24, 2026 4 min read
The FDA isn’t experimenting with AI anymore — it’s operationalizing it.
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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
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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
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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
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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
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