Pro QC International is a provider of MDSAP (Medical Device Single Audit Program) audit services in China, delivering customized solutions to meet the unique requirements of the medical device industry.
Our focus is on aiding companies to navigate the complexities of MDSAP, verifying their supplier compliance, and improving the quality of their medical device production.
With offices in Shenzhen, Shanghai, and Ningbo, and a network of auditors across key manufacturing regions in China, Pro QC International offers MDSAP audits nationwide.
Our auditors and medical device consultants, knowledgeable in MDSAP protocols, have a profound understanding of conducting these specialized audits throughout China. They are experienced at identifying potential risks or areas that may impact the quality, safety, and regulatory compliance of medical devices. Our approach encompasses a thorough review of the entire product lifecycle, from design and development to post-market surveillance, under the MDSAP framework.
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With offices in strategic locations such as Shenzhen, Shanghai, and Ningbo, Pro QC International offers MDSAP audit services throughout China
Our MDSAP Audit and Consulting Services in China
With over four decades of experience in quality auditing, Pro QC is a trusted partner for MDSAP audits. Pro QC customizes solutions to each client’s specific needs, deploying auditors to act as their representatives on the ground, identifying non-compliance or issues that could affect their business objectives and regulatory adherence.
The MDSAP audits provided by Pro QC in China cover critical aspects like device marketing authorization, design and manufacturing processes, and adherence to the specific regulatory requirements of participating MDSAP countries. Our services extend beyond audits, as we offer guidance and support in MDSAP implementation, ensuring a smooth journey towards compliance and successful audit outcomes.
Clients can rely on our comprehensive support from the initial audit planning to the implementation of corrective actions and ongoing compliance management.
Our Team of MDSAP Auditors in China
Pro QC’s MDSAP auditors are selected through a rigorous recruitment process, based on their experience, competencies, and specific certifications related to the medical device industry. This ensures that our MDSAP audits are delivered by highly specialized professionals.
In China, our auditors bring their knowledge of the local manufacturing environment, regulatory landscapes, and international medical device standards. They are trained to conduct ISO 13485 and MDSAP audits, ensuring that medical device manufacturers meet the rigorous requirements of the participating regulatory authorities.
Pro QC International leverages over four decades of experience in quality auditing to deliver customized solutions tailored to each client’s specific needs
Other Medical Device Audits Offered in China
As a consulting company specializing in medical device audits, the range of solutions we provide to our clients in China extends beyond MDSAP and includes the following audits:
- ISO 13485 Audits – Quality Management System for Medical Devices
- ISO 14644 Audits – Cleanroom Environments for Medical Devices
- ISO 11135 Audits – Sterilization of Healthcare Products (Ethylene Oxide)
- ISO 11137 Audits – Sterilization of Healthcare Products (Radiation)
- FDA 21 QSR 820 – Quality System for Medical Devices (U.S. Regulation)
Key Differentiators
- Superior industry and technical expertise garnered since 1984
- 3 offices in Shenzhen, Shanghai and Ningbo, China
- ISO 9001 Certified Company
- Tailored auditing solutions provided in over 88 countries
- Specialized and qualified medical device auditors
- Detailed audit reports delivered within 48 hours
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