Medical QMS and ISO 13485 Audit Services in China

Pro QC International is a trusted provider of ISO 13485 audit services in China, specializing in comprehensive solutions tailored to the medical device industry. Our consulting services are designed to assist companies in ensuring compliance with the ISO 13485 standard, a critical component for manufacturers within the medical device sector.

Our skilled team of auditors and consultants, possessing extensive experience and certifications, conducts ISO 13485 audits across China. We focus on identifying potential risks and non-conformities that could affect the quality and safety of medical devices. Our audits also assess areas for improvement in manufacturing processes, quality management systems, and regulatory compliance.

Pro QC’s ISO 13485 audit services encompass a thorough examination of a manufacturer’s adherence to the standard, including evaluations of product design, development processes, and risk management procedures. We also assist companies in implementing and maintaining the ISO 13485 standard, guiding them through the certification process with expert training and support.

With offices in key locations like Shenzhen, Shanghai, and Ningbo, and a network of professional auditors throughout China’s major manufacturing hubs, Pro QC International offers extensive coverage and support for ISO 13485 audits nationwide.

Conducting ISO 13485 audits in China entails identifying potential risks and non-conformities that may impact the quality and safety of medical devices

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Our ISO 13485 Audit Services in China

Pro QC has over 40 years of experience in quality auditing, with a significant focus on the medical device industry and compliance with ISO 13485. We offer a variety of solutions, including:

  • ISO 13485 Quality Management System Audits
  • Supplier Management and Evaluation
  • Internal Audits for ISO 13485 Compliance
  • Preparation for the Certification
  • Training and Implementation Support for ISO 13485
  • Corrective and Preventive Action (CAPA) Audits

Our tailored solutions involve deploying auditors to medical device manufacturers, acting as an extension of our client’s team to identify areas of non-compliance and potential risks. Clients can count on our comprehensive support, from initial audits to the implementation of improvements and ongoing compliance maintenance.

To learn more about our ISO 13485 audit solutions and discover our audit checklist, please visit our dedicated page here ISO 13845 audits.

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Our Team of Consultants and ISO 13485 Auditors in China

To qualify as a Pro QC auditor, candidates undergo a rigorous selection process, ensuring they have the necessary experience, skills, and certifications. This stringent process guarantees that our ISO 13485 audit services are delivered by experts in the medical device industry.

In China, our auditors are certified and possess deep knowledge of the medical device sector, local regulations, and quality assurance practices. They are trained to conduct thorough audits that meet our client’s specific needs, providing valuable insights and recommendations for improving compliance and quality performance in the medical device industry.

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Our audits evaluate areas for enhancement in manufacturing processes, quality management systems, and regulatory compliance to ensure optimal product performance and adherence to international standards

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Working with an ISO 13485 Consulting Company in China

Conducting ISO 13485 audits in China is crucial for companies in the medical device industry aiming to ensure compliance, product quality, and patient safety. Regular audits help identify and mitigate potential risks, quality issues, and regulatory non-compliance. These audits are also vital for evaluating the performance and capabilities of suppliers and manufacturing facilities, enabling strategic and informed decision-making.

Furthermore, ISO 13485 audits in China support companies to adhere to global regulatory requirements and demonstrate a commitment to producing safe and effective medical devices. Pro QC, with its experienced and certified auditors, is uniquely positioned to offer precise and customized ISO 13485 audit consulting services in China.

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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 ISO 13485 and includes the following audits:

  • 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)
  • MDSAP – Medical Devices Single Audit Program
  • FDA 21 QSR 820 – Quality System for Medical Devices (U.S. Regulation)

Our team also offers combined audits such as:

  • ISO 13485 + Cleanroom Audits
  • ISO 13485 + EU MDR
  • ISO 13485 + Sterilization Process Audit
  • And more

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Key Differentiators

  • Superior industry and technical expertise garnered since 1984
  • 3 offices in Shenzhen, Shanghai and Ningbo, China
  • ISO 9001 Certified Offices
  • Tailored auditing solutions provided in over 88 countries
  • Specialized and qualified auditors
  • Detailed audit reports delivered within 48 hours

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