When sourcing wound care products for European markets, two terms appear again and again: CE marking and ISO 13485. Understanding them helps procurement teams compare suppliers with confidence.
CE marking
CE marking shows that a medical device meets the applicable European requirements and has gone through the relevant conformity assessment.
ISO 13485
ISO 13485 is the international standard for quality management systems in medical device manufacturing. It covers design, production, traceability and continuous improvement.
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