ISO 13485 & IVDR-Compliant Contract Manufacturer in Germany for Proteins, Antibodies & Assays
Quality and regulatory compliance are top priorities at ASKA Biotech. Our ISO 13485:2016 certification confirms that our quality management system meets all requirements for the development and manufacturing of proteins, immunoassay kits, and the measurement of human serum and plasma for in-vitro diagnostics under the strict In Vitro Diagnostic Regulation (IVDR).
This certification applies to all major service areas – from our Custom Assays, Antibody Production and Recombinant Protein Production to Transfection Services. It ensures that our processes are standardized, traceable, and performed at a consistently high quality level.
With our ISO 13485 certification in Germany, we guarantee maximum regulatory security, support your IVDR technical documentation, and offer the high standards of a specialized local partnerfor your international projects.
What Does ISO 13485 Certification Mean?
ISO 13485 is the internationally recognized quality standard for manufacturers in medical technology and the prerequisite for compliance with the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR). Companies certified to this standard must demonstrate that their development and production processes are:
- fully documented,
- risk-based,
- validated and traceable,
- and auditable at any time.
For customers, this means maximum process reliability, minimized regulatory risk for IVDR conformity assessment, and dependable compliance with European and international requirements.
ISO 13485–Certified Contract Manufacturing at ASKA Biotech
Our ISO 13485 certification covers all key biotechnology service areas at ASKA Biotech:
Why Choosing an ISO 13485 Contract Manufacturer Matters
In protein, antibody and assay development, precise process control is essential. ISO 13485 ensures:
Standardized and validated workflows
All critical steps – from cell culture to expression and final quality control – are strictly monitored and performed according to documented SOPs.
Full traceability throughout the entire production process
Every batch, reagent and customer lot is completely traceable.
Simplified IVDR Approval Process
ISO 13485 certification fulfills key requirements for IVD applications. We provide comprehensive documentation (SOPs, batch records) that you can directly integrate into your IVDR technical file.
Reliable and reproducible results
Reproducibility and lot-to-lot consistency are essential for research, diagnostics and product development.
Your Benefits: Certified Quality Made in Germany
For international partners, we serve as a reliable ISO 13485 Certified Contract Manufacturer for advanced biotech and IVD projects. Based in Hennigsdorf near Berlin, we offer:
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short communication routes
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high delivery reliability
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German quality standards
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state-of-the-art laboratory environment
Download ISO 13485 Certificate
FAQ – Frequently Asked Questions about ISO 13485 Contract Manufacturing
What does ASKA Biotech’s ISO 13485 certification confirm?
It confirms that our entire contract manufacturing process—from development to final QC—ensures full traceability, risk management, and consistent quality suitable for the IVD industry.
Does your manufacturing support IVDR compliance?
Yes. Our ISO 13485:2016 certified processes are designed to support your compliance with the In Vitro Diagnostic Regulation (IVDR). We provide the necessary documentation for your technical files.
Is ASKA Biotech a certified manufacturer in Germany?
“Yes. We are an ISO 13485 certified contract manufacturer based in Hennigsdorf/Berlin, Germany. Our quality standards are internationally recognized.
Can we conduct a supplier audit at your facility?
Absolutely. Transparency is key to our quality philosophy. We welcome supplier audits to verify our facilities, processes, and documentation standards firsthand.
