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Start to finish certify one device
All technical documentation needed - ISO 14971, IEC 62304, IEC 62366 and more
Quality Management System compliant with ISO 13485
Streamlined document approval and lifecycle management with the built in eQMS
One-click technical file generation ready for notified body submission
Your documents are yours. Export them at any time
Documentation checked by our CE Audit experts
Weekly 1:1 with our regulatory experts for guidance and progress validation
