Standardized production is an important aspect of the production process in medical technology, as medical devices and products must be produced and marketed according to strict laws and regulations. As part of the Medical Device Directive and the Medical Devices Act, there are a large number of standards and regulations that companies must observe if they wish to successfully place their product on the German and European market. This does not only apply to the marketers, but also to suppliers and OEMs.
The senetics healthcare group GmbH & Co. KG can assist you with all steps around the compliance and introduction of the different standards. Two of these important standards are DIN EN ISO 13485 and DIN EN ISO 14971, which deal with quality management and risk management of medical devices. These standards must be met in order for a product to pass the conformity procedure and thus obtain a CE mark.
The technical documentation is also an important part of this process. We can help you with this documentation and the backup.
- Introduction to DIN EN ISO 13485 & DIN EN ISO 14971
- Internal Audits & Qualification of suppliers
Documentation & Data Backup