Required Labeling per IEC 60601-1-2
Per IEC 60601-1-2, clause 5 there are over 20 labeling requirements to address in your Instructions for Use (IFU). Not all requirement apply to every device.
Regulators have been known to reject submissions if there are labeling errors. This can result in costly delays for the device approval. We use a detailed checklist to insure that all the details are correct.
It is highly recommended to include in your test report a checklist to each requirement listed in clause 5 as evidence of compliance.
Regulators have been known to reject submissions if there are labeling errors. This can result in costly delays for the device approval. We use a detailed checklist to insure that all the details are correct.
It is highly recommended to include in your test report a checklist to each requirement listed in clause 5 as evidence of compliance.