
News: UK Regulatory Authority Launches Consultation on CE Marking
The UK regulatory authority opens a consultation on CE mark recognition and highlights other key global regulatory updates.
Updates, guidance and expert perspectives on regulatory affairs, compliance and market access across Brazil, the United States and Europe.

The UK regulatory authority opens a consultation on CE mark recognition and highlights other key global regulatory updates.

Global updates on MDR and IVDR, the QMSR in the U.S., and new regulatory requirements for cosmetics in

Understand the impacts of the EU MDR IVDR on the European market and the key global regulatory movements

Discover the truth behind the “Anvisa bans fiberglass nails” topic and explore other important regulatory updates.

Learn how to navigate the Anvisa medical device registration process and bring your product to the Brazilian market

Anvisa has automated the issuance of certificates through the Solicita system. Learn what changes in the Anvisa AFE

Finding the correct technical name for your IVD in Anvisa’s database can be challenging. Learn how to do

Key changes for your biocompatibility strategy.
A practical guide to understand the 2025 update and what it means for your medical device documentation.
CLIENT VOICES
“
“Sobel provided a friendly, goal-oriented service with fast solutions. We look forward to working together on future projects.”

Andreas Kohl
CEO · Andratec
“
“I experienced always supportive, pro-active collaboration from Sobel Consult with high degree of competency in broad regulatory range.”

Mandy Blocher
Expert Regulatory Framework & Digital Transformation · Aesculap AG (B. Braun)

Clear regulatory direction
The right pathway and priorities for your product.

Fast and responsive support
We act quickly to keep projects moving.

Practical guidance
Actionable advice for your next step.
To provide the best experiences, we use technologies such as cookies to store and/or access device information. Consenting to these technologies allows us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent may negatively affect certain features and functions.