osapiens and PTC Announce Partnership to Advance MedTech Compliance

Mannheim, Germany / Boston, MA, May 13th, 2026. osapiens, a leading provider of enterprise software for sustainable growth and regulatory compliance, today announced an official technology partnership with PTC, a global leader in product lifecycle management (PLM) software. The partnership brings together two complementary platforms: PTC Windchill, the industry standard for product, regulatory, and quality data management, and the osapiens HUB for Medical Devices, a purpose-built solution for UDI data management and regulatory submissions. Together, they help MedTech companies address the growing complexity of global compliance requirements.

EUDAMED (the European Database on Medical Devices and the EU's central registry for market surveillance, device traceability, and safety reporting) becomes mandatory on May 28, 2026. At the same time, Unique Device Identification (UDI) requirements continue to expand across global markets, including the United States (GUDID), Australia (TGA), and Switzerland (SWISSDAMED). MedTech companies are under increasing pressure to ensure that product data is accurate, complete, and submitted to the right regulatory authorities on time.

"Windchill is where the world's leading MedTech manufacturers manage their complete product, regulatory, and quality data. Regulatory compliance is inseparable from that foundation. osapiens brings deep expertise in global UDI submissions and regulatory data management, complementing what Windchill delivers. Together, we give our joint customers a stronger position for navigating an increasingly complex regulatory landscape”, said Rene Zoelfl, Global MedTech Advisor, PTC.

"MedTech companies face a growing gap between the product data they manage in their PLM systems and the regulatory submissions they need to deliver to authorities around the world. Our partnership with PTC brings together the leading platform for product lifecycle management and the leading platform for regulatory data submission. Our joint customers can now close that gap with the right expertise on both sides of the equation", said Henning Jaeger, Director Healthcare, osapiens.

The osapiens HUB for Medical Devices enables manufacturers to centralize, validate, and submit product data to EUDAMED (EU), GUDID (USA), SWISSDAMED (CH), TGA (Australia), and further global registries from a single platform, maintaining a fully auditable, QMS-compliant record of all submissions and status updates. PTC Windchill serves as the system of record for product and quality data at many of the world's leading medical device companies, providing the lifecycle management foundation on which compliant product development depends.

MedTech companies are also facing new obligations under the EU Packaging and Packaging Waste Regulation (PPWR), which introduces strict requirements for packaging sustainability, recyclability, and reporting. The osapiens HUB addresses these requirements on the same platform, enabling MedTech companies to manage UDI compliance and packaging obligations, as well as Digital Product Passport (DPP) requirements in a single, integrated environment.

PTC's installed base includes the majority of the world's top medical device manufacturers, making this partnership a significant step in osapiens' expansion in the life sciences sector and in North America, a key strategic growth market. Beyond UDI and regulatory submissions, the partnership lays the foundation for broader collaboration across product compliance, supply chain transparency, and operational efficiency — addressing challenges that extend beyond medical devices to adjacent regulated industries such as aerospace and industrial manufacturing.

About osapiens

osapiens develops software that empowers companies to drive sustainable growth across their entire value chain.

The osapiens HUB, a multi-tenant hyperscaler platform designed to enable cross-company collaboration and AI-automation, combines over 25 solutions in two categories: Transparency solutions enable companies to report on financial and non-financial data, manage supply chains, mitigate risk of all kinds (including cyber-risks and trade- and geo-political risks), and ensure compliance with product, reporting and supply chain regulations. Efficiency solutions enable AI-driven supplier collaboration, maintenance, service, and distribution processes to improve operational performance and strengthen competitiveness.

osapiens was founded in 2018. Headquartered in Mannheim, Germany, with offices across Europe and the United States, the company works with an international team of over 550 employees. It supports more than 2,400 customers worldwide, from SMEs to global enterprises across industries.

About PTC (NASDAQ: PTC)

PTC (NASDAQ: PTC) is a global software company that enables industrial and manufacturing companies to digitally transform how they engineer, manufacture, and service the physical products that the world relies on. Headquartered in Boston, Massachusetts, PTC employs over 7,000 people and supports more than 30,000 customers globally. For more information, please visit www.ptc.com.