Medical Devices — Engineered for Compliance

Medical devices demand the highest tier of supply chain rigor — ISO 13485 quality systems, design controls, validated processes, and complete traceability from raw material to shipped unit. Vakerus connects medical device companies with verified contract manufacturers experienced in Class I and Class II devices, including disposables, diagnostics, wearables, and accessories. We manage design history file documentation, process validation (IQ/OQ/PQ), incoming material inspection, sterile and non-sterile packaging, and FDA 510(k) and CE MDR documentation support. Our team works alongside your regulatory affairs team to keep submissions on track. Every batch is documented, every change controlled, every shipment traceable.