Meeting the EU MDR Regulations

In response to the EU MDR regulations for medical devices, Malone Group was appointed to scope and project manage the incorporation of Unique Device Identifier (UDI) barcodes into our customer’s range of products. Our scope of work includes preparation of funding applications, URS/IQ/OQ/PQ protocols, upgrade and qualification of various labelling machines, on-line inspection systems, barcode verification systems along with co-ordination of artwork development, quality risk assessments and new SOP developments – all within an aggressive 9-month timeframe.

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