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Quality is the cornerstone of trust and reliability in the in vitro diagnostics (IVD) industry. By maintaining high standards and adhering to rigorous quality-control processes, we at Medix Biochemica can help our IVD customers deliver accurate and dependable test results – today and far into the future.1
| High-quality IVD raw materials → High-quality, reliable IVD tests → Reliable results for healthcare providers to make the right decisions. |
An ongoing commitment to product quality and performance
Our mission is to ensure the reliability and consistency of our products, which are critical for the success of our customers' diagnostic tests. Quality in the form of product performance and consistency:
- Helps customers provide reliable results to patients and healthcare providers.
- Streamlines the development of assays through performance and batch-to-batch consistency.
- Eliminates waste, including wasted time, resources and materials when repeating experiments or checking unreliable data.
As evidenced year after year in our annual customer survey, Medix Biochemica is highly regarded for the quality and performance of our products.
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“In our 2025 annual customer survey, customers listed high product performance and quality in 35% of responses – the most of any category.” - Anthony Austin, Global Marketing Manager, Medix Biochemica |
We pride ourselves on the safety and performance of our raw materials, which are essential for accurate IVD testing. By providing high-quality products, we help our customers avoid the risks associated with false-positive results, ensuring reliable diagnostic outcomes.
Read more: False Positives: What are the Risks?
Medix Biochemica’s commitment to excellence is not only reflected in our innovative products and services, but also validated by our globally recognized ISO certifications. These credentials underscore our dedication to maintaining the highest standards in the IVD industry.2
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About ISO certifications
The ISO (International Organization for Standardization) is an independent, non-governmental international organization made up of 170 national standards bodies. These bodies work to develop official international standards that are voluntary, consensus based and market relevant.3,4
Most Medix Biochemica's manufacturing sites follow strict quality-management systems (QMSs) and are ISO 13485 or ISO 9001-certified.
- ISO 9001 is an internationally recognized standard for QMSs. It provides a framework for organizations to put in place the right processes and trained staff in order to consistently deliver effective products and/or services.5
- ISO 13485 is the internationally recognized standard for QMSs which have been specifically developed for the design and manufacture of medical devices. The requirements of ISO 13485 are in place to ensure that these devices meet regulatory demands and customer expectations for safety and efficacy.6
Commitment to quality through regulatory compliance1
Medix Biochemica's commitment to quality and ISO certifications significantly benefits our customers, particularly those in the IVD industry. Our adherence to the current ISO standards, including ISO 9001 and ISO 13485, ensures that our manufacturing sites maintain strict QMSs. This dedication to quality makes it easier for our customers to achieve their own ISO certifications, by streamlining the process of establishing a compliant supply chain.
Long-standing certification1
As an example, our headquarters in Espoo, Finland has held an ISO 13485 certificate for over 20 years. This long-standing certification underscores our reliability and consistency in delivering high-quality IVD raw materials. By partnering with Medix Biochemica, customers can trust that they are receiving compliant and reliable products that meet stringent regulatory requirements.
Navigating the regulatory landscape1
The ever-changing regulatory landscape of the IVD industry demands constant vigilance and adaptability. New regulations and updates to the regulatory framework for medical devices emphasize the need for safety, supply security and accuracy in testing. Medix Biochemica's ISO certifications and rigorous QMSs ensure that our products meet these evolving requirements, helping our customers navigate regulatory changes smoothly.
Supporting regulatory compliance1
Medix Biochemica also supports customers in meeting tightening regulations within their market areas by offering scientifically justified products and rapid responses to scientific inquiries. Our expertise and tailored services enable our partners to get to market quickly without compromising on quality. We assess our raw material suppliers to ensure consistent quality and sustainability, providing excellent lot-to-lot consistency in our manufacturing processes.
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Our attention to quality control during product testing, continuous process improvement and regulatory compliance means we are always audit ready and prepared to support our customers with their own regulatory compliance as well.1 |
Read more: Overcoming IVD Regulatory Hurdles with Medix Biochemica
Our ISO certifications and unwavering dedication to quality benefit our customers by ensuring reliable, high-performance IVD raw materials. Our commitment to maintaining the highest standards helps our customers achieve compliance, meet regulatory requirements, and deliver accurate diagnostic results, ultimately supporting better patient outcomes.1
Read more: ISO 13485 Certification: A Guide for IVD Startups
View Medix Biochemica’s quality certifications2
Medix Biochemica Headquarters
Medix Biochemica France (Diaclone)
Medix Biochemica Konstanz, Germany (myPOLS Biotec)
Medix Biochemica FL, USA (Bioresource Technology)
Medix Biochemica MO, USA
Through rigorous quality-control measures, continuous process improvement and careful adherence to regulatory requirements, Medix Biochemica offers our customers consistently exceptional product quality and performance.1
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Contact the Medix Biochemica Team to discuss your requirements:
References
- Expert opinion. Anthony Austin. Global Marketing Manager, Medix Biochemica. January 2025.
- Our IVD certifications and quality assurance. Medix Biochemica. Accessed January 27, 2025. https://www.medixbiochemica.com/certifications.
- ISO - About us. ISO. Accessed January 27, 2025. https://www.iso.org/about-us.html.
- What we do. ISO. Accessed January 27, 2025. https://www.iso.org/what-we-do.html.
- ISO 9001 certification - Quality management standard. NQA. Accessed January 27, 2025. https://www.nqa.com/en-in/certification/standards/iso-9001.
- ISO 13485:2016. ISO. Accessed January 27, 2025. https://www.iso.org/standard/59752.html.
