Quality management in a closed, efficient process.
Uncompromising quality and innovative products – quality assurance as guiding principle.
Consistent quality orientation is the basis for reliable, safe products and innovative developments. Ensuring and optimizing this along the entire process chain are the core of the Wirthwein Medical quality management that is anchored and standardized in each of our factories. Based on a certified, integrated management system, we meet all requirements of our customers, the regulatory requirements of the test institutes for our clean room processes and the requirements for sustainable, resource-saving production. Each process step is monitored and documented. Simultaneous or subsequent test procedures ensure constant high product quality for every quantity.
- DIN EN ISO 13485
- DIN EN ISO 9001
- DIN EN ISO 15378
- ISO 50001
- DIN ISO 10001
- Class 7 clean room production according to DIN EN ISO 14644-1
- GMP requirements (Good Manufacturing Practice)
- We also take account of elements from the regulations and standards 21 CFR 820 Quality System Relations (Medical Devices) and ISO/TS 16949.
Our keys for reliable and reproducible quality:
Employee qualification
We are already forming the basis for the future qualification and specialization of our employees with our in-house training. Regular internal and external further training measures and the annually held safety, GMP, hygiene and clean room training courses provide continuous know-how transfer.
Material quality
The quality of our plastics starts with the specification of our suppliers, clearly defined incoming goods inspections (including raw material retention samples) and ends with the targeted, application-compliant material selection. Regular supplier audits and material tests secure the varietal purity of our thermoplastics.
Qualification and validation
We succeed in achieving efficiency and stability in the process using systematic qualification and validation measures. These include initial sample reports, clearly defined qualifications such as DQ, IQ, OQ and PQ and the execution of fill studies and optimization loops.
High level of automation
Automated handling systems guarantee defined removal and storage of the molded parts from the tool. Semi and completely automated packaging, assembly and test processes minimize wear, tolerance value and error rate.
State-of-the-art measuring technology
On-site, we provide you with a wide range of standardized and product-specific test procedures, e.g. 100% in-line camera inspections, optical quality and dimensional measurements, measuring microscopy, tensile testing machines and 3D coordinates measurement technology.