Seamless Test Approval and Timely Market Introduction: Medix Biochemica’s Advantage

Getting regulatory approval for products is one of the biggest hurdles facing in vitro diagnostic (IVD) test manufacturers.¹ By partnering with an IVD material supplier like Medix Biochemica, however, you can rest assured that all your raw testing ingredients are correctly certified, which helps to speed up the approval process and ultimately decreases the time to market.¹

What Causes Delays in Getting IVD Tests to Market?

Common delays faced by IVD test manufacturers include:¹

Regulatory hurdles
Manufacturing challenges 
Supply chain issues, such as shortages of certain materials
Securing funding 
Market factors, e.g. if the market trends towards a new priority like an unexpected pandemic

Read more about how IVD regulation and requirements can change over time.

The Right IVD Supplier Can Help to Mitigate Delays

What to look for in an IVD supplier:¹

High-quality products
ISO certification
Supply chain reliability
Transparency and traceability 
Scalability 
 Flexibility 
Competitive pricing
Global reach

When it comes to providing IVD materials, Medix Biochemica checks all of these boxes.

Partnering With Medix Biochemica For Your IVD Material Needs

At Medix Biochemica, we understand that time is of the essence for our customers. In an era where speed and precision are paramount, the quality of our IVD materials helps to shorten our customers’ time to market.²

Leveraging our expertise and streamlined workflows, we've honed a finely tuned approach that ensures quality and batch-to-batch consistency. This helps to minimize unnecessary regulatory and quality-related delays and accelerate the journey from product inception to launch.²

Ultimately, Medix Biochemica provides peace of mind – as a customer, you can rest assured that our IVD raw products are properly certified, traceable and scalable.¹

Stringent quality-management system³

We manufacture to high quality requirements, including those spelled out in ISO 13485:2016, or ISO 9001:2015, as applicable. 

Consistency³

With our state-of-the-art in vitro production equipment, Medix Biochemica can produce large batches of IVD and MDx reagent products with the highest quality and batch-to-batch consistency.

Scalability³

We can manufacture batch sizes from milligrams to kilograms!

Flexibility¹

We are agile and flexible, which allows us to meet the needs of a dynamic and fast-changing market. For example, during the COVID outbreak, we were able to divert our resources to meet the urgent needs of our customers, with the help of our established network of partners.

Customer focus¹

With Medix Biochemica, you can expect expert-to-expert communication. When you contact us, you’re talking one-on-one to a real individual who understands the industry and can discuss your specific needs.

Traceability: where to find our product certificates³

Most of the information you need to know about our individual products can be found on their datasheets, available for download on their respective product pages on our website. However, SDS (Safety Data Sheets), CoAs (Certificate of Analysis) and CoCs (Certificate of Conformity) are also available to customers.

For direct inquiries, you can contact sdsrequest@medixbiochemica.com for SDS requests and orders@medixbiochemica.com for CoA and CoC requests.

Our commitment to quality empowers our customers to seize competitive advantages and deliver groundbreaking solutions to the ever-evolving healthcare landscape. With Medix Biochemica as your trusted ally, your vision becomes reality faster than ever before.²

References:

1. Expert opinion. Interview with Anthony Austin, Global Marketing Manager at Medix Biochemica. November 1, 2023. 
2. Expert opinion. Information provided by Anthony Austin, Global Marketing Manager at Medix Biochemica. November 2023. 
3. FAQs. Medix Biochemica. Accessed November 10, 2023. https://www.medixbiochemica.com/faqs