Qserve Group: Your Global MedTech Partner

/write/fotoset/24/regulatory_consultant_qserve.jpg?preset=PhotoSet_Rundown /write/fotoset/24/02.jpg?preset=PhotoSet_Rundown /write/fotoset/24/clinical_affairs.jpg?preset=PhotoSet_Rundown /write/fotoset/24/04.jpg?preset=PhotoSet_Rundown

September 04, 2024

Key Strategies for Successfully Passing NMPA Inspections for Medical Device Manufacturers | Part 7. China NMPA Inspection results and common findings

The NMPA (National Medical Products Administration) is responsible for regulating medical devices in China. In Part 7 of our blog series, we explore the most common findings from NMPA inspections and offer key insights for manufacturers to strengthen their quality systems. By understanding these frequent issues, such as design and development or production management, manufactures can better prepare for inspections and ensure compliance with NMPA regulations.

Why choose Qserve as your regulatory consultant?

We know exactly what should be prepared to become and stay in compliance with the regulations
Strong international team with technical, regulatory quality and clinical competence
Ex EU Notified Body, FDA, and CFDA staff
Full medical device CRO services
We have a multifaceted team ranging from junior to principal consultants and depending on your project, we can form a cost-effective team and strategy
We charge you for the work performed, no hidden costs
We train and we leave something behind, a regulatory compliance imprint
One contact point giving you access to a broad team with all expertise
Legal representation in China, Europe and the United States

Our method

"Our mission is to support all medical device and IVD manufacturers with a practical approach, translating existing regulations to understandable requirements."

Jan van Lochem , CEO