QbD Group

QbD Group specializes in supporting Medical Device and IVD companies in bringing their innovations to market faster and more efficiently. Our experts provide high-level Quality Assurance, Regulatory Affairs, and Compliance services that help companies navigate the complex and evolving regulatory landscapes of the EU, US, and China.

Our goal is to reduce the regulatory burden and associated risks for our clients, ensuring smoother and more predictable approval processes. Whether you're a startup preparing for your first submission or an established company expanding internationally, we work closely with organizations to streamline compliance and help you focus on what matters most—delivering safe, effective technologies to patients and healthcare providers.