Quality Policy

Our policy

We make instruments that a clinician holds in one hand at the moment it matters most. That is the whole standard, and everything below is how we hold ourselves to it.

Quality Never Die. It is a promise about the instrument in the customer's hand and about the way we work when nobody is watching.

The standards we work to

• ISO 13485:2016, the quality management system our processes, records and audits are built around.
• EU MDR 2017/745, the regulation our devices are placed on the European market under, including unique device identification and the technical documentation behind it.
• ISO 14971, the risk management standard applied to every device from design through production and post market experience.
• IEC 60601, applied to our electrically powered devices, including the video laryngoscope range.

How we hold to it

• Every batch and every powered device carries an identity, a lot number or a serial, that can be traced back to the material it was made from and the people who made it.
• Measuring instruments are calibrated on a schedule, and an instrument past its date does not get used.
• A nonconformity is recorded, contained and dispositioned by a review board, not quietly reworked.
• Complaints are investigated against the batch and the build record, and the finding goes back into the process.
• Our people are trained against the controlled document that governs their work, and the training record says so.