Specialists in regulation for medical devices, biocides, and cosmetics
MD Sur Consulting was founded with a clear mission: to provide regulatory and documentary support to companies seeking to bring medical devices and cosmetic products to market with full guarantees.
Our work consists of converting complex regulations into an actionable plan, with correct documentation, traceability, and continuous compliance.
About Us
Consultancy and advisory specialists in regulatory affairs.
Medical Devices Sur Consulting is a consultancy and advisory firm specialized in regulatory guidance and the management of procedures for marketing medical devices and cosmetics.
Our focus is centered on ensuring regulatory compliance and excellence within the pharmaceutical sector.
We Provide Support
The primary purpose of Medical Devices Sur Consulting is to provide regulatory support for medical devices, in vitro diagnostic medical devices, cosmetics, and biocides to companies whose ultimate goal is to place their products on the market under the legal guarantees this entails.
To this end, Medical Devices Sur Consulting will accompany you throughout the entire process, starting from legal consultancy support to verify that the product complies with all legal guarantees established by Regulation (EU) 2017/745 on medical devices, Regulation (EU) 2017/746 on in vitro diagnostic medical devices, Regulation (EU) 2023/607 amending Article 120 of Regulation 2017/745, Royal Decree 192/2023 regulating medical devices at the national level, Regulation (EC) 1223/2009 on cosmetic products, and Regulation (EU) 528/2012 concerning the making available on the market and use of biocidal products.
Furthermore, we offer guidance throughout all necessary legal procedures to market your product, as well as supervision and the constant activities required to maintain it on the market under the corresponding legal protection.
Our Mission
Our mission is to accompany our clients at every stage of the process to market their products, from initial advice to obtaining certifications such as the CE marking, product registration, and the management of licenses and responsible declarations.
