Quality Management System
Process-oriented quality assurance is our priority number one!
We manufacture and develop medical devices and assessories, such as high-quality components for heart-lung machines, dialysis machines, flow measurement systems, cardiac support systems and industrial flow meters, e.g. for the bioprocessing technology. We offer medical devices under our own brand, but we are also OEM supplier and thus an important partner of numerous large medical technology companies. The contract development for medical devices is one of our core competences, therefore we are very familiar with the regulatory requirements in medical technology. Our quality management system is certified according to ISO 13485 and also meets the requirements of the 21 CFR 820 (GMP, US-FDA).
We commit ourselves to the highest quality standards for our products and services through our quality management system. Our daily mission is to provide competent advice and correct order processing for our customers and users taking into account state-of-the art and future legal requirements, standards and guidelines!
Our QM system complies with the following standards:
- DIN EN ISO 13485:2016 (certified by TÜV Süd)
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This ISO standard is detailing the requirements for a comprehensive management system for the design and manufacture of medical devices.
- EU Directive 93/42/EEC (certified by TÜV Süd)
This medical device directive is the most important regulatory instrument for demonstrating safety and medical as well as technological functionality of medical devices within the European Economic Area.
This directive specifies how the electromagnetic compatibility of electrically operated devices in the European internal market is to be achieved.
- EU Directive 2011/65/EU (RoHSII)
The directive RoHS II is intended to limit the use of certain hazardous substances in electrical and electronic equipment and regulates the use and the placing on the market of hazardous substances in electrical appliances and electronic components.
- 21 CFR 820 (GMP, US-FDA, Qualitätssicherung)
Requirements for the quality management system of manufacturers of medical products, exporting to the USA (good manufacturing practice for medical devices/GMP).
- NRTL current (Inspections by TÜV Süd)
NRTL inspections for USA and Canada.
- J-QMS (Confirmation Letter)
Regulatory requirements for manufacturers of medical devices for the Japanese market.
We use the Application Life Cycle Management Software Tool „Polarion“ to support development, verification, requirements management and documentation.