ISO 13485 Audit Services in Vietnam
Medical QMS and ISO 13485 Audit Services in Vietnam
Vietnam is a fast-growing hub for medical device manufacturing in Asia. Pro QC International supports this growth by offering ISO 13485 audit services tailored to international buyers and Vietnamese manufacturers. We help companies align with global regulatory expectations by verifying that their quality management systems (QMS) meet ISO 13485:2016 standards.
Our ISO 13485 audits in Vietnam are designed to support manufacturers at every stage of the quality journey—whether you’re preparing for certification, evaluating your internal systems, or assessing your suppliers. With a clear understanding of both local manufacturing practices and international requirements, our team helps ensure your medical devices meet strict safety and quality standards.
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Enhance manufacturing performance and strengthen compliance with ISO 13485 audits tailored to Vietnam’s fast-growing medical device industry
Our ISO 13485 Audit Services in Vietnam
We provide end-to-end audit solutions for the medical device sector in Vietnam. Our services include:
- ISO 13485 QMS Audits: Comprehensive audits of your quality system to ensure alignment with ISO 13485:2016 requirements.
- Supplier Audits: Evaluations of your critical suppliers to determine their ability to meet your quality and compliance standards.
- Internal ISO 13485 Audits: Objective internal audits to identify gaps, prepare for external audits, and maintain compliance.
- Certification Readiness Support: Gap assessments and advisory support to help you prepare for third-party ISO 13485 certification audits.
- QMS Implementation and Training: Practical support for companies building or updating their ISO 13485-compliant systems, including documentation and staff training.
- CAPA Reviews: Focused audits of Corrective and Preventive Action processes to ensure issues are properly identified and resolved.
Each service is delivered with attention to your production scope, regulatory targets, and timeline. We offer both on-site and remote audits across Vietnam.
Our Team of Consultants and ISO 13485 Auditors in Vietnam
Pro QC’s Vietnam-based auditors and consultants are qualified professionals with strong backgrounds in medical device manufacturing, quality assurance, and regulatory compliance. All auditors are trained to conduct audits in line with ISO 19011 and ISO 13485 guidelines, and many bring sector-specific knowledge in orthopedics, electronics-based devices, and sterile manufacturing.
Our team understands the realities of manufacturing in Vietnam, including common quality challenges and the expectations of regulators and global buyers. They conduct every audit with an eye on long-term improvements, helping clients enhance efficiency as well as compliance.
Auditors are available in Ho Chi Minh City, Hanoi, Da Nang, and other key manufacturing zones, ensuring responsive service wherever you operate.
Identify risks, uncover non-conformities, and reinforce device safety through ISO 13485 audit insights aligned with global regulatory expectations
Working with an ISO 13485 Consulting Company in Vietnam
Ensuring ISO 13485 compliance is critical for Vietnamese companies aiming to export medical devices to Europe, North America, or Japan. Third-party audits are not only essential for certification readiness but also provide internal value by identifying process weaknesses, reducing quality risks, and improving traceability.
When you work with Pro QC, you benefit from:
- Guidance tailored to your company size, industry segment, and product type
- Independent assessments by certified auditors
- Clear, structured audit reports with improvement recommendations
- Insight into international quality expectations, including EU MDR and U.S. FDA regulations
We act as a partner throughout your compliance journey—not just as an auditor, but as a resource to strengthen your QMS.
Other Medical Device Audits Offered in Vietnam
Beyond ISO 13485, Pro QC provides additional audit solutions to support companies working in regulated healthcare environments:
- Cleanroom Audits (ISO 14644)
- Sterilization Audits (ISO 11135 & ISO 11137)
- FDA 21 CFR Part 820 Audits
- MDSAP Support
We also provide combined audits, which are often required by clients with multiple compliance obligations:
- ISO 13485 + EU MDR Readiness
- ISO 13485 + Sterilization Validation
- ISO 13485 + Cleanroom Compliance
Key Differentiators
- Superior industry and technical expertise garnered since 1984
- Local office in Ho Chi Minh City, Vietnam
- Tailored auditing solutions provided in 100 countries
- Specialized and qualified ISO 13485 auditors
- Detailed audit reports delivered within 48 hours
To discuss your needs for ISO 13485 audit services in Vietnam or to receive a proposal, contact us here. We’re ready to support your compliance efforts wherever your operations are based.
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+49 15630 810151
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+91 120 508 9113
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+886 2 2832 2990
Stability
Pro QC has been providing quality assurance, engineering and consulting services since 1984.
Global Presence
We offer a dedicated Account Manager and quality solutions in over 100 countries.
Timely Feedback
We offer online reporting and detailed reports within 24 hours of job completion.
Quality Experts
Our global engineering team has the requisite industry expertise to verify quality and conformance.