We have manufacturers, suppliers and service providers from the area Services according to DIN EN ISO 13485 requirements in medical technology

DIN EN ISO 13485 is the globally recognized standard for the quality management of medical devices. Its requirements focus on the operational organization of manufacturers, service providers, and medical product companies, as well as the minimization of clinical risks. The standard emphasizes the importance of process-oriented presentation of company-specific management and core processes. These processes should be implemented in a systematic way and documented properly. This way, it will be easier for medical device manufacturers to demonstrate compliance with the standards and achieve regulatory approvals.

The German standard DIN EN ISO 13485 defines the requirements for a quality management system for medical devices. This certification ensures that a manufacturer is meeting the required standards and avoiding potential recurrence of risks. This certification is also recognized internationally and allows medical device companies to promote their products. This standard has become an industry standard for medical devices, and em-tec is pleased to be certified to meet its requirements.

The medical device marketability criteria required by DIN EN ISO 13485 include the demonstration of suitability and usefulness of the medical device. These requirements include the selection of qualified personnel, appropriate application of the medical device, and quality assurance during the whole lifecycle. In order to comply with the standards, the company must demonstrate its processes are effective and that the documentation is complete and up-to-date. Furthermore, the certification will provide a guarantee of the effectiveness of the processes used to produce the products.

Simon Hegele has implemented a quality management system that complies with DIN EN ISO 13485:2016. The company is expanding its logistics services for medical device manufacturers. The DQS MED GmbH certification confirms that the company meets the highest standards for quality management of medical devices. The quality management system covers contract manufacturing, storage, picking, packaging, labelling, and contract manufacturing. These processes help the company meet the regulatory requirements for medical devices.

The German-based Reinhausen Plasma Group has been certified according to DIN EN ISO 13485:2016, and is pursuing the certification of a similar system in the United States. The company's quality management system has been certified by DQS MED GmbH, a certified company that meets the highest standards for medical device companies. The certificate covers all aspects of contract manufacturing and storage. Its certificate will also prove that the system complies with the requirements of the European Union.

ISO 13485 requirements are applicable to medical device organizations. They are also beneficial to many other organizations, including suppliers and external third parties. The ISO 13385-compliant quality management system has a third-party review of the quality management system, which offers both internal and external verification for customers. With the third-party review, the company can gain confidence in its ability to meet regulatory requirements. With the help of the third-party audit, the company can also save time and money.