Sandra Ferretti is Chief Compliance Officer and Board Member at Obelis Group, working daily at the heart of regulatory complexity. Beyond compliance, she is also a singer. In this interview, she reflects on how structure and creativity come together in her life and influence the way she leads.
The EU has unveiled a proposal to simplify the MDR and IVDR framework, introducing updates designed to ease compliance and support innovation. Here’s what’s changing and what manufacturers need to do next.
Obelis Group supported RF Medical Co., Ltd. with the efficient issuance of EU Free Sales Certificates, enabling compliant and timely medical device registrations in Jordan and Vietnam to support global market expansion.
Obelis Group supported RNDENT, a manufacturer of Class I dental medical devices, with a seamless MHRA registration update during account renewal, ensuring uninterrupted access to the UK market through efficient and compliant regulatory support.
EUDAMED becomes mandatory on 28 May 2026. Discover key deadlines for actor, device, and certificate registrations under MDR and IVDR, and how to prepare.
Obelis COO Doram Elkayam shares how he navigates complex EU, UK, US, Swiss and Canadian regulations to streamline multi-market access for medical devices, IVDs, cosmetics and more. In this interview, he reflects on 2025, key trends for 2026, and why smart regulatory strategy is now a business essential.
Kind Patches Ltd. partnered with Obelis Group to build a clear, future-proof compliance strategy for launching nutrient-delivery wellness patches in the EU and UK. Through in-depth regulatory research, step-by-step consultancy, and EU/UK GPSR compliance reviews, Obelis helped transform complex requirements into a structured pathway for confident market entry and long-term growth.
Discover how Boundless Devices Inc., a U.S.-based technology company, successfully entered the EU market in just 7 days. With Obelis Group’s VIP service and EAR support, the company achieved fast and seamless compliance under the Radio Equipment Directive (RED), transforming regulatory complexity into a confident and efficient EU market launch.
Gideon Elkayam, Obelis Group’s CEO shares how the company transformed from an EU Authorized Representative into a global compliance partner, turning regulatory complexity into confidence, faster market access, and sustainable growth for manufacturers worldwide.
The European Commission has announced new cosmetics compliance deadlines affecting Retinol, Triclosan, and several nanomaterials. From late 2025, products containing these ingredients must meet stricter safety limits or be withdrawn from the EU market. Learn what these changes mean for your formulations and labelling.