Case Study 27 : QMS ISO 13485 Audit of Suppliers for US Based Medical Devices Company

Company Situation

The Client is a medical devices company that developed proton therapy devices that are like radiation therapy devices targeting tumors with precision. The Client had suppliers in global, non-US locations and wanted to partner who could enable Client with ISO 13485 compliance by auditing 3rd parties in the supply chain.

GRP Solution

GRP’s global team in USA and Europe helped client prepare a complete audit plan for assessing their suppliers based in multiple locations in Europe. GRP’s team brings decades of experience from medical device industry and ISO 13485 requirements and has helped over 300 manufacturers to stay compliance with QMS requirements. GRP was helped the client right from audit planning, preparing for audit, conducting the audit and submission of reports with findings and recommendations to Client for further actions.

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China's NMPA

In China, the regulating Health Authority is  The National Medical Products Administration (NMPA) also formerly known as the China Food and Drug Administration or CFDA). The NMPA is a vice-ministerial-level administrative agency under the State Administration for Market Regulation (SAMR).