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LUMED's origins

Quality and safety

Responsabilità ambientale

Radici italiane, connessioni globali

Innovazione e inclusione

Qualità e innovazione
Learn more about our quality policy

Quality policy

LUMED wants to be a company able to adapt its competitive ability and its processes over time in order to react to the changing conditions of competitiveness and the changing requirements of modern medicine.

LUMED is firmly convinced that growth, the obvious goal of any company, has to be pursued without any sacrifice and compromise as regards respecting and protecting the customer while operating in compliance with legislative provisions.

Our quality policy embraces this simple and concrete concept:

“assess each action in terms of sustainability”

The Risk/Benefit and Cost/Benefit ratios must be clear to our clientèle. Only an “aware” purchase can be defined “sustainable” by LUMED.

LUMED operates by clearly defining tasks and responsibilities, stimulating collaboration and allocating adequate resources for continual improvement of the corporate management system. To this end, the medium- and long-term aims are clearly defined during the systematic company progress review activities.

LUMED aims at dedicating the necessary attention and the right amount of time to the customer, also at a stage other than purchasing: in that way we want to assess as best we can that we meet the customer’s expectations, considering that only a satisfied customer will remain faithful and bring new customers in.

LUMED is certain that every investment in this direction is the best contribution to achieving stable, long-lasting and sustainable growth objectives.

We therefore focus our efforts on activities that create value for our customers, shareholders, employees, sales partners and other holders involved, making quality and compliance with the essential safety requirements our benchmarks.

Rintracciabilità
Learn more about medical device traceability

Commitment to traceability of medical devices

The harmonized standard UNI CEI EN ISO 13485:2016 requires documented procedures to identify products using appropriate means starting from their receipt through all the treatment phases up to delivery and installation at the end user. To this end, all the products manufactured and/or marketed by LUMED S.r.l. have a Batch Number indicated on the package in order to allow their traceability in compliance with the regulations in force on medical devices.

The Batch Number is also indicated on the DELIVERY NOTE and the accompanying INVOICE.
It is essential that your internal organization ensure that the information necessary for product traceability towards your customers is maintained in order to allow effective corrective actions in the field in the event of incidents in compliance with the requirements of the medical device standard and MEDDEV 2.12-1 rev.8.

In order to act in the best interest of the customer, we therefore ask you to market our products in such a way that the information necessary for their proper use, traceability and origin is always maintained.

Furthermore, LUMED must be notified of any technical or commercial problem relating to the Medical Device as required by the regulations and the laws in force. Should you need further clarification and information, please contact us..