Faq category: Regulatory & Quality

Can you handle both cold chain and ambient shipping for freeze-dried reagents?

Yes. Our logistics support both cold chain and ambient shipping to ensure the integrity of freeze-dried reagents and other components. We partner with you to select the optimal shipping method based on stability data.

What documentation package can you provide with each batch?

Every batch includes comprehensive documentation: batch records, QC results, and a Certificate of Analysis (CoA), all aligned with our ISO 13485 certification.

What is the minimum batch size for RUO kit manufacturing?

We specialize in small- to medium scale production with flexible batch sizes tailored to early-stage development, clinical studies, and initial commercialization efforts and market penetration. This enables cost-effective testing and iteration without large upfront investments.

What is the typical lead time for pilot batch manufacturing?

Lead times are optimized for speed, typically ranging from 3 to 6 weeks depending on product complexity and specific requirements . We prioritize rapid turnaround for pilot studies.

Can Future Diagnostics assist with technology transfer and scale-up for manufacturing?

Absolutely. Once your assay is validated, we manage a smooth technology transfer from FDx to our internal manufacturing department or to external manufacturing partners. This includes SOPs, batch records, pilot production, and scalability assessment to ensure consistent performance at commercial scale.

Does Future Diagnostics offer support for early-stage feasibility or proof-of-concept studies?

Yes, we provide early-stage feasibility and proof-of-concept services to help clients determine technical viability before full-scale development. This includes material sourcing, small-scale reagent testing, signal optimization, and preliminary performance assessments—ideal for startups and pharma R&D teams exploring new biomarkers or assay formats.

How does Future Diagnostics manage project timelines and costs?

We follow an agile project management approach, using KPIs to track budget, quality, and time. Clients receive regular updates via our secure SharePoint portal and frequent project meetings. Transparent communication and clear milestones help minimize risks and ensure predictable timelines.

Is your lab compliant with global standards?

Yes. Our facility in Wijchen, the Netherlands operates under ISO 13485:2016. We also meet requirements for IVDR, and other international standards, ensuring global compliance for your product.

Can Future Diagnostics help with IVDR compliance for IVD assays?

Yes. We support companies preparing for IVDR (In Vitro Diagnostic Regulation) by performing analytical performance validation studies, collecting the required samples, identifying both documentation and performance gaps, and preparing regulatory files. We follow the latest CLSI guidelines and IVDR Annex I & II requirements, streamlining your path to CE marking.

How do you ensure quality and regulatory compliance?

We operate under strict ISO 13485 quality standards and offer regulatory support, including assay performance evaluation under IVDR (EU In Vitro Diagnostic Regulation)