Our quality policy is based on an extensive definition of the term „quality“. We do aim for the consistently highest possible product quality, while also our internal company processes are tightly controlled, and subject to fixed specified quality standards. In this context special attention is given to all those activities at the direct interfaces to all our clients of nerbe plus GmbH, and the production line. The quality management system of nerbe plus GmbH is based on the 8 QMS elements of DIN EN ISO 13485 under consideration of the requirements according to directive 93/42 EWG (medical device directive). The relative official certification of the company forms the basis for quality and trust. These are our principles with which we have aimed to win your confidence and trust in the past, and which we will be committed to also in the future. We will continue in our efforts to maintain highest quality standards also in view of the up-dated state-of-art of science and technology.
The quality of nerbe plus GmbH is based on the following principles:
Quality is the prime task of the management, all our employees, and depart-ments of nerbeplus GmbHto ensure among each other, and in close cooperation with our appointed quality manager alike. Pro-active quality management means setting realistic forecasts andimplementing the goals set in accordance with schedules agreed upon.Our common objective target is to rather prevent any possible quality problemand related additional cost, instead of later corrective action.The principle of constant feedback is applied in all directions.The main goal remains the desire for a continuously improved quality and customer satisfaction, an early recognition of possible mistakes and active mea-sures to avoid their recurrence by consequently targeted and planned action.Quality must be verifiable and comprehensible Detailed documentation, moni-tored quality audits, and systematic evaluations give proof of all quality-related
What are medical devices?
Medical devices are all devices used alone or in combination, instruments, software, material, equipment or other items that are determined by the manufacturer to be used for human beings for the purpose of:
What are In Vitro Diagnostics (IVD)?
In vitro diagnostic (IVD) is a term for medical devices for medical laboratory testing of samples originating from the body. These samples are analyzed outside the body.
In vitro diagnostic (IVD) is any medical device which is a reagent, reagent product, calibrators, control material, kit, instrument, apparatus, equipment or system - individually or in conjunction with each other - after the set from the manufacturer to be used in vitro investigation is used by derived from the body specimens, including blood and tissue donations, solely or principally for the purpose of providing information:
With the CE marking on a product the manufacturer confirms that the product complies with the conditions laid down in the EU Directive requirements for products of this type and, as necessary, the required test method has been subjected.
The manufacturer shall affix the mark to the product and in addition created a Declaration of Conformity, which certifies that the product complies with the cited regulations and standards.