MDR has reshaped the European regulatory landscape for light therapy devices, making compliance a critical part of product development and market access. From classification to post-market surveillance, it demands full-lifecycle commitment—and LTV is built to support you at every step.

Bringing a light therapy device to the European market requires more than innovation—it demands full regulatory alignment. CE marking proves your product is safe, compliant, and ready for legal distribution, giving your brand a competitive edge and access to the entire EU market.

ISO13485-certified manufacturing is the gold standard for light therapy devices, ensuring safety, compliance, and quality at every stage of development. For brands aiming to enter global markets with confidence, this certification builds trust, streamlines regulatory approvals, and delivers consistently reliable products.

Choosing European development for light therapy devices means combining scientific innovation, precise engineering, and regulatory expertise to create high-performance, market-ready products. With English communication, ISO13485-certified processes, and trend-driven design, it’s a smart foundation for brands seeking quality, speed, and global compliance.

What does FDA clearance mean for light therapy devices? Learn about the classification, approval pathways, and why it matters for market access.