Osmunda Medical Device Industry Group
Empowering Innovation in the Medical Device Industry

OSMUNDA, a global leading technology service provider for medical devices and in-vitro diagnostics (IVDs) has grown to stand as a frontrunner in providing comprehensive consulting services and marketing authorization supports. As a third-party service provider for medical devices and IVDs, the firm offers one-stop medical device industry solutions for developers, manufacturers, users and governments worldwide.

“We equip the industry with global marketing authorizations, regulatory supports, clinical trials (CRO), contract manufacturing (CDMO), as well as platforms for medical device management cloud, medical-engineering cooperation and incubation, and industrial investment services,” says Min Yang, the regulatory and clinical affairs, country manager, Germany branch at Osmunda Medical Device Industry Group.

The company’s core expertise lies in assisting clients with specialised medical product marketing authorization services. By closely following local policies and regulations and understanding the essential features of clients’ medical products, OSMUNDA devises efficient strategies to expedite approval timelines and reduce costs. From creating technical documentation to facilitating communication with regulatory authorities and notified bodies, its dedicated team guides clients through their medical devices’ registration process, ensuring compliance and conducting risk assessments. Due to its commitment to being updated with evolving regulations, OSMUNDA helps clients to efficiently comply with the latest industry standards and achieve the desired outcomes.

The company has developed a platform—the largest for medical engineering cooperation and medical device incubation in China— that incorporates relevant regulations and a registered product database and project management system.

This platform enables clients to stay informed through regular industry newsletters and track the progress of their ongoing projects, ensuring transparency and effective collaboration.

OSMUNDA’s success is underpinned by its team of approximately 290 professionals who possess extensive knowledge and experience in regulatory bodies, device manufacturing and clinical institutions. Led by industry veteran Kevin Zhang, the team is well-equipped to deliver exceptional results for clients’ projects. The company also takes pride in its best-in-class production facilities in China, spanning over 20,000 square meters in major cities nationwide. These production facilities also enable clients to quickly and efficiently bring their products to market.

We equip the industry with global marketing authorizations, regulatory support, clinical trials (CRO), contract manufacturing (CDMO), as well as platforms for medical device management cloud, medical-engineering cooperation and incubation, and industrial investment services

A case study that elucidates the competence of the company’s services is its interaction with a client seeking to introduce a class III medical device to the Chinese market, which usually necessitates extensive clinical studies in China. Upon collaboration, OSMUNDA devised and leveraged a highly effective strategy called the green channel approach—an accelerated pathway for examining and approving innovative medical devices. The firm recommended the client target the Hainan province as the initial entry point, enabling rapid market access within three months. This allowed them to quickly start using their products in China and collect valuable real-world data while significantly reducing time to market. Consequently, the client achieved their desired outcomes, successfully navigating regulatory hurdles and gaining a strong foothold in the Chinese market.

OSMUNDA’s dedication to driving innovation in the medical device industry is evident in its continuous pursuit of cutting-edge solutions and its proactive approach to staying ahead of industry trends. Through its comprehensive services, strategic partnerships and dedication to corporate social responsibility, the company continues to empower clients, shape industry standards, and transform healthcare for societal growth.