MEDICAL DEVICE
Regulatory expertise
for medical devices.
We help medical device companies navigate complex regulatory pathways and access regulated markets worldwide.
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Fast answers, clear direction, and practical regulatory support.
“Sobel provided a friendly, goal-oriented service with fast solutions. We look forward to working together on future projects.”
Andreas KohlCEO - Andratec
Latest insights
Insights and updates to help you navigate compliance with confidence.
Medical devices
News: ISO 10993-1:2025 Is Now ABNT NBR – What It Means for ANVISA
ISO 10993-1:2025 is now ABNT NBR in Brazil. See what changes in biological evaluation for ANVISA registration.
October 14, 2026
Medical devices
EUDAMED Deadline 2026: What to Do Before 27 November
Your devices have been on the EU market for years. They have valid certificates,
September 28, 2026
Medical devices
FDA and Generative AI-Enabled Medical Devices: What the 2026 Discussion Paper Signals for Manufacturers
Generative AI medical devices are moving into a new regulatory phase. In its 2026
August 31, 2026
