Compliant Transition for Global Operations

Situation

A global provider of at-home aesthetic and beauty devices, operated with its Legal Manufacturer address in Israel while much of its commercial activity focused on Europe and North America. Due to geopolitical developments affecting operational stability in the region, they decided to transfer its Legal Manufacturer address to the Netherlands and phase out its remaining organizational activities in Israel. The transition required careful planning and coordination. This provider needed to maintain regulatory compliance, ensure market continuity, and preserve effective design control and supplier oversight throughout the process.

Capabilities

This global provider needed an experienced partner that could take responsibility for the regulatory, quality, and operational activities associated with its new Legal Manufacturer structure. Rather than building a new internal quality, regulatory, and clinical organization, they chose to partner with BAAT Medical. BAAT combined regulatory expertise, quality management experience, and operational capabilities to support them during the transition. This approach allowed them to maintain control of its product portfolio while continuing to focus on its commercial strategy and international markets.

Solution

BAAT continued operating exclusively under their existing QMS and managed the regulatory, quality, and operational activities required to transition to the Dutch legal manufacturer structure. BAAT coordinated with their suppliers and supported the distribution network across the EU and North America, ensuring uninterrupted design control and documentation. A dedicated Quality Manager oversaw their ongoing QMS responsibilities, while BAAT provided day-to-day support and ensured MDR preparedness for products classified as medical devices.

Result

The relocation of this legal manufacturer address to the Netherlands was completed smoothly, without disruption to supply chains, distribution activities, or regulatory compliance. Through BAAT’s management of design control, supplier coordination, and global regulatory support throughout the transition, this global provider was able to maintain business continuity and focus fully on its commercial operations. The company now operates from a stable and compliant legal manufacturer structure serving both EU and North American markets.