For companies that manufacture In Vitro Diagnostic (IVD) products, implementing a quality management system is not just a regulatory requirement it is also a key driver of reliability and sustainability in the market. In this context, the ISO 13485:2016 standard plays a critical role in enhancing the competitiveness of IVD manufacturers both nationally and internationally.
At SZUTEST, we actively provide ISO 13485 certification services as an accredited certification body, leveraging our specialized expertise in the medical device sector. With our extensive experience, technically competent auditors, and process-focused approach, we bring value to every step of your certification journey—not only certifying your system but also fostering a culture of quality.
Why Choose Us?
- Accredited Certification Body: We offer fully compliant, reliable, and traceable audit processes under ISO 17021 and ISO 13485 standards.
- Expertise in IVD & IVDR-Compliant Approach: We have deep knowledge of the technical documentation structure, risk management, performance evaluation processes, and new requirements introduced by (EU) 2017/746 IVDR for IVD manufacturers.
- Field-Proven Experience: Our auditors are well-versed in all stages of the IVD product lifecycle, delivering a professional and informed audit experience.
Our Goal: Stronger Services with Notified Body Status
In addition to our strong certification services in the IVD field, we are also actively progressing in the process of being designated as a Notified Body (NB) under IVDR. With this vision, we aim to be not only your trusted certification partner today but also your long-term solution provider for future regulatory needs.
Let us support your journey toward compliance and excellence in the IVD sector with confidence, competence, and commitment.