Our products have an influence on people's health. biocon and all its employees do bear a special responsibility for this. None of our working steps is carried out without prior training and intensive briefing, not only in production, but also in administration and in all areas of incoming and outgoing goods. Careful quality control in all areas is particularly important to us, which is why we attach great importance to ensuring that sufficient time is available for this.
For us, quality management means manufacturing high-quality sterile medical devices, living quality and constantly optimizing our QM system and adapting it to growing demands. Quality, fast problem solving and customer satisfaction are our top priorities. The recording of all processes from development to shipping guarantees a consistently high level of quality. Each production step is controlled and documented. The traceability of all processes is possible without any gaps and offers additional transparency to the users. Our QM system not only covers product-related processes such as purchasing, production, storage and distribution, but also includes hygiene, cleaning, machinery and work safety. Our management system ensures that we achieve the quality demanded by our customers and at the same time guarantee the safety of our medical devices as required by law.
"Customers and auditors evaluate our quality management system as extraordinarily effective and targeted. In regular internal audits, we check ourselves and systematically eliminate identified deficiencies. We gladly accept suggestions for improvements to our quality management system and work as a team to find practicable solutions." Katharina Schaber, Head of Quality Management
Incoming goods, in-process and final controls are carried out beyond the prescribed requirements where special responsibility for the patient is involved. Qualified and experienced employees in all areas and their continuous training ensure a high level of product safety. We manufacture in clean rooms whose hygienic conditions are subject to regular external and internal controls in order to identify and minimize potential risks at an early stage.
We are certified according to DIN EN ISO 13485:2021 and Directive 93/42/EEC, Annex V. Certification in accordance with Directive 93/42/EEC is an absolute requirement for the CE marking of our Class IIa, Is and Im medical devices.
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