ISO 13485 Is é teastas an ticéad iontrála, ní an cruthúnas. Léigh an ráiteas scóip agus an seoladh deimhnithe, seiceáil go bhfuil an teastas reatha, agus a dheimhniú go bhfuil an comhlacht eisiúna creidiúnaithe do dheimhniú feiste leighis. Ansin lorg na hiompraíochtaí a bhfuil deimhniú ceaptha a ráthú.
Cigireacht ag teacht isteach agus rialú comhpháirteanna
Socraítear feidhmíocht optúil an leaba teiripe solais dhearg críochnaithe ag earraí isteach. Iarr ar thaifid iniúchta ag teacht isteach a fheiceáil maidir le tonnfhad LED agus le haghaidh binneáil flosc, baisceanna tiománaí, aicrileach nó ábhar painéil, agus na rialaitheoirí. Déanfaidh monarcha a ghlacann le haon bhosca bruscair a dhéanfaidh na longa dáiliúcháin leapacha a tháirgeadh a mbeidh a haschur ag imeacht idir ritheanna táirgeachta, agus tabharfaidh do chustaiméirí faoi deara an difríocht sula ndéanann tú.
Electrical safety testing should be performed on every red light therapy device rather than on a sample. A hipot and earth continuity test recorded against each serial number is the minimum, and the records should be retained for the period your regulator expects.
Traceability and change control
Ask whether a serial number can be traced back to the LED lot, the driver lot, the assembly operator, and the test record. If the answer requires a manual search through paper, the system exists but will not scale to your volumes.
Change control is the item buyers forget and later regret. You need a written commitment that no bill-of-materials change, however small, ships without your written approval. A substituted driver can improve the factory’s margin, invalidate your EMC report, and change the thermal profile of the product, all without a single visible difference on the outside of the bed.
