quality

The importance of high quality standards for medical devices

In manufacturing, quality is a state of being free from defects, deficiencies and significant variances. We work exclusively with development and production of medical devices. As these products and components have a significant impact on human lives, patient safety is our top priority. All our quality activities have one common goal, to avoid any defects and variations, and to ensure a documented traceability.

Every aspect of the development, from design to distribution, must meet strict quality standards. Not only our customers, but also vendors, suppliers, contractors, OEMs and third parties need to be sure that their products comply with medical device laws and regulations.

Meeting international and individual standards for medical products

We offer our customers high competence based on our long experience and continuous education within RA/QA. In order to maintain and our high quality, while having the capacity to meet the increasing regulatory requirements, we have quality assurance departments in our various subsidiaries to ensure we meet international certification standards, and the standards that the individual countries set for medical products.

The requirements involve tasks such as developing documentation, manufacturing prototypes and implementing subsequent testing in our own laboratories. These tests are both static and dynamic and mainly focus on durability. Production of pre-series is always done on the machines where the series production will occur, which permits validation in a large-scale environment and is an effective way of safeguarding the quality requirements.

Double-checking all critical measurements to reduce costs

In order to reduce our customers’ costs, we have implemented electronic measurement value management, where we double-check all critical measurements. This enables us to deliver straight to your stock without additional customer inspections. We strive to make our measuring instruments as operator-independent as possible. This has resulted in our ultramodern machine park with both optical and detecting measuring machines of the highest quality.

Full traceability with all our products

Naturally, we have full traceability (DHR) with all products. This means total traceability regarding all events and documents, from the design stage to production, checks and delivery.

Our offering of solutions and services within quality and regulatory is a part of Elos Medtech Complete Performance™.