Zilyc helps life sciences organizations successfully transfer new products from R&D into scalable, compliant manufacturing. Our integrated approach combines project management, regulatory foresight, and technical documentation to reduce risks and accelerate time to market.
Whether you’re developing diagnostic assays, instrumentation, or medical devices, our team ensures your design transfer process is efficient, traceable, and audit-ready.
We work with your R&D, engineering, and operations teams to plan and execute smooth design transitions. Our strategies minimize production delays, compliance gaps, and costly revisions.
Our services include:
We ensure your design intent is preserved from prototype through full-scale production.
Robust verification and validation protocols are essential for quality assurance and regulatory approval. Zilyc supports V&V strategies that meet FDA, ISO 13485, and EU MDR requirements.
Our services include:
We guide your team in demonstrating that products meet design and performance expectations, backed by clear documentation and technical integrity.
Effective risk management is a cornerstone of successful product development. Zilyc helps identify, assess, and mitigate risks throughout the design lifecycle.
Risk-related services include:
From early-stage design to post-market monitoring, our risk strategies support product safety, regulatory approval, and user trust.
Zilyc brings together technical expertise, project execution, and deep regulatory knowledge to streamline your design transfer and risk management efforts.
We offer:
Whether launching a new diagnostic cartridge or scaling an assay to global production, we align strategy with execution—every step of the way.
Design transfer is the structured process of converting a validated design into manufacturing specifications. It ensures that a product can be reliably and compliantly produced at scale. Poorly executed transfers can lead to quality issues, delays, or regulatory nonconformance.
A clear transfer plan, collaborative cross-functional teams, accurate documentation (DHF, DMR), validated manufacturing processes, and aligned supplier relationships all contribute to a smooth design transfer.
Risk management helps identify and mitigate potential failures before they affect product quality or patient safety. It’s a regulatory requirement under ISO 14971 and is essential throughout the lifecycle—from design input through post-market surveillance.
Risk assessments should start at the concept phase and evolve with each stage of development. Zilyc helps ensure that risk activities are proactive, documented, and integrated into your QMS.
RPartner with Zilyc to transform complex designs into market-ready, compliant products. Contact us today to discuss how we can guide your next transfer project from planning through production.
We delivers tailored solutions in biomanufacturing, quality systems, and supply chain optimization, driving efficiency and compliance in the life sciences industry.
© Copyright 2025 Zilync Biosolutions
