Luxe Assist Global Inc. partnered with Obelis Group to streamline compliance, refine labelling, and confidently achieve a smooth, delay-free UK market entry for their microneedle derma roller.
News
Obelis Group Participates as Contributing Partner in the 10th ERPA Annual Summit 2026
Obelis Group will participate as a Contributing Partner in the 10th ERPA Annual Summit 2026, a key European forum uniting regulators and industry experts to discuss evolving expectations in EU cosmetics compliance and the practical responsibilities of the Responsible Person.
Finding the right balance: Sandra Ferretti on leadership and creativity
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.
EU Proposal to simplify MDR and IVDR: what it is and why it matters
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.
Accelerating Global Expansion Through Expert EU Regulatory Support
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.
Seamless MHRA Updates Enabling Continued Market Access for Dental Devices
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: deadlines for actor, device, and certificate registrations
EUDAMED becomes mandatory on 28 May 2026. Discover key deadlines for actor, device, and certificate registrations under MDR and IVDR, and how to prepare.
Leading Through Complexity: Doram Elkayam, on Multi-Market Compliance and the Road to 2026
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.
Strategic Compliance for a New Generation of Wellness Products
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.
EU Market Entry Success Story: RED Directive Compliance in 7 Days with Obelis VIP
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.