October 5, 2023

Why Your Contract Manufacturer Should Have an ISO 13485 Certification

You want to bring your IVD product to market and outsource your protein or immunoassay production? Discover why your contract manufacturer must have a DIN EN ISO 13485 certification of their production processes and your added value!


Significance of ISO 13485 Certification

Certification of in vitro diagnostic (IVD) and medical device production according to DIN EN ISO 13485 is important for several reasons:

  1. Ensuring compliance with regulatory requirements: ISO 13485 certification is mandatory for the approval and market launch of IVD and medical devices. The standard ensures that a company’s quality management system complies with applicable regulations and requirements. The IVDR (In Vitro Diagnostic Device Regulation) also mandates compliance with ISO 13485.
  2. Safeguarding continuous product quality: The standards set forth in ISO 13485 ensure that a company is capable of consistently producing high-quality products. The quality management system must cover the entire manufacturing and testing process, from planning to delivery of the final product. By adhering to the standard, potential risks are identified and minimized to ensure the safety of patients and users.
  3. Robust control processes throughout the value chain: ISO 13485 focuses on controlling processes along the entire value chain. Every step of production must be carefully monitored and controlled to ensure compliance with regulatory requirements and avoid shortcomings. This ensures reliable and reproducible product quality.

ISO 13485: A Must for Your Contract Manufacturer

When outsourcing production, ISO 13485 certification of your contract manufacturer’s production processes is crucial:

  1. Avoid additional effort and costs: If your contract manufacturer does not have ISO 13485 certification, they will need to undergo extensive supplier audits to ensure they meet the required quality standards. This can be time-consuming, costly, and lead to unnecessary project delays. If it shakes out that the requirements of the IVDR cannot be met due to inadequate provisions, you will need to identify and qualify a new contract manufacturer/supplier.
  2. Streamline audits: If your contract manufacturer’s production is already ISO 13485 certified, your supplier audits can be conducted more efficiently.
  3. Facilitated approval process: By providing relevant and comprehensive documentation and data for regulatory approval, you save time and make the approval process more efficient.
  4. Ensure quality-oriented supplier management: With ISO 13485 certification, you can be confident that only high-quality materials are used in your products.
  5. Potential sources of errors can be detected early: By applying a risk-based approach, potential pitfalls can be mitigated even before the start of the project.
  6. Robust testing assures continuous quality: Products and services undergo meticulous testing processes throughout their lifecycle to guarantee stable product quality.

ASKA Biotech: Your Reliable Partner with DIN EN ISO 13485 Certification

Looking to bring your IVD product to market while outsourcing your protein / antibody or Immunoassay production?

ASKA Biotech is your partner for your outsourcing needs. With our specialization in antibody & protein production, purification processes, and Immunoassay production, we guarantee excellence at every step.

At ASKA Biotech, you benefit from our ISO 13485 certification to ensure smooth production processes with the highest quality:

    1. Seamless partnership: Say goodbye to the tedious search for a qualified partner! We are ready to embark on a hassle-free partnership with you.
    2. Unwavering dependability: Trust is the foundation of any successful collaboration. With ASKA Biotech, you can fully rely on us to deliver. Our commitment to meeting your requirements is unwavering, giving you peace of mind throughout the entire process.
    3. Understanding your needs: Communication is key to a fruitful partnership. At ASKA Biotech, we speak your language right from the start. We understand your unique needs and tailor our services accordingly, ensuring a seamless and personalized experience.


We Speak YOUR Language When It Comes to Quality Requirements 

DIN EN ISO 13485 Requirements ASKA’s Commitment
Chapter 1: Scope We manufacture your proteins and immunoassay kits and measure your human sera and plasmas.
Chapter 2: Normative References We fulfill all legal requirements for your IVD approval.
Chapter 3: Terms and Definitions We speak the same language.
Chapter 4: QMS Our QMS ensures continuous product quality.
Chapter 5: Management Responsibility We are aware of our responsibility to provide reliable raw materials and stand by it.
Chapter 6: Resource Management We provide you with our optimally coordinated resources, including personnel, equipment, and infrastructure.
Chapter 7: Product Realization Together, we realize your product from idea to planning, development, and market readiness.
Chapter 8: Measurement, Analysis, and Improvement Benefit from our continuous improvements through ongoing monitoring of processes.