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 From late 2025, products containing these ingredients must meet stricter safety limits or be withdrawn from the EU market.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.
Australia, often referred to as the skin cancer capital of the world, is facing a…
Since 2024, the European Commission has been conducting a targeted evaluation of the EU Medical Devices Regulations (MDR and IVDR). The Parliament as well as many Member States have called for a simplification of the regulations, together with business associations from the medical device sector.
The EU In Vitro Diagnostic Regulation (IVDR) formally known as Regulation (EU) 2017/746replaces the former…
Manufacturers of Class D IVDs must sign an agreement with a notified body by 26 September 2025 to benefit from IVDR transitional periods. Learn about the deadlines, requirements, and how Obelis supports the process.
In 2025, the EU introduced Omnibus Acts VII and VIII, banning and restricting several substances in cosmetics due to CMR classifications. These changes require immediate compliance. Learn how Obelis can help ensure your products meet the latest regulations.