The Medical Device Regulation (MDR) ensures improved safety standards in the manufacture of medical devices.The goal of increasing patient trust in medical technology and ensuring reliable healthcare poses a number of challenges for medical device manufacturers.When implementing the MDR, manufacturers are often dependent on the support of their suppliers along the entire supply chain.ODU deals intensively with the provisions of the MDR and supports its customers in implementing the requirements.
For more than 80 years, ODU's own research and development has been the most important basis in the manufacture of connectors and cable assembly at the highest level.Changing conditions and new requirements are always taken into account.The connector manufacturer has also familiarized itself with the requirements and guidelines on the subject of MDR and keeps up to date with all changes and updates to ensure that the processes in the background are always compliant.This applies both to the standard portfolio and to the tailor-made solutions, in which ODU works closely with its customers – so individual requirements can be taken into account and connectors can be designed that fit perfectly with the desired applications and at the same time comply with the MDR guidelines.
At ODU, however, compliance with the MDR does not begin with the production of connectors, but extends to every step of the supply chain.ODU attaches great importance to careful supplier selection with high standards in terms of quality and compliance with the MDR.Furthermore, attention is paid to compliant documentation and traceability along the entire supply chain.Risk management in accordance with the requirements of the ISO14971 and consistent change management have been implemented.The identification of CMR substances in the materials used as well as the full data storage according to the individual requirements are also guaranteed - and this for a period of up to 30 years!
ODU experts provide full support
For example, laser marking of the connectors as part of the production process enables clear traceability of each product.In this way, the provisions of Unique Device Identification (UDI) are complied with.Through intelligent design, compliance with 2MOOP/2MOPP within the framework of IEC 60601-1 can be achieved on the connector itself – saving the customer additional design effort for this part of his application.The developers at ODU are always busy further optimizing the product range – of course in close cooperation with the customers.ODU customers can rest assured that they are sourcing high-quality and safe connectors that meet the highest standards of medical technology.
For more information on how ODU deals with MDR, visit the website at https://odu-connectors.com/industries/medical/, watch our new video on the topic https://vimeo.com/871384902 or talk to our experts in person - for example, from 13.11.2023 to 16.11.2023 at Compamed in Düsseldorf, Germany, at booth P19/Hall 8a.
For more than 80 years, ODU's own research and development has been the most important basis in the manufacture of connectors and cable assembly at the highest level.Changing conditions and new requirements are always taken into account.The connector manufacturer has also familiarized itself with the requirements and guidelines on the subject of MDR and keeps up to date with all changes and updates to ensure that the processes in the background are always compliant.This applies both to the standard portfolio and to the tailor-made solutions, in which ODU works closely with its customers – so individual requirements can be taken into account and connectors can be designed that fit perfectly with the desired applications and at the same time comply with the MDR guidelines.
At ODU, however, compliance with the MDR does not begin with the production of connectors, but extends to every step of the supply chain.ODU attaches great importance to careful supplier selection with high standards in terms of quality and compliance with the MDR.Furthermore, attention is paid to compliant documentation and traceability along the entire supply chain.Risk management in accordance with the requirements of the ISO14971 and consistent change management have been implemented.The identification of CMR substances in the materials used as well as the full data storage according to the individual requirements are also guaranteed - and this for a period of up to 30 years!
ODU experts provide full support
For example, laser marking of the connectors as part of the production process enables clear traceability of each product.In this way, the provisions of Unique Device Identification (UDI) are complied with.Through intelligent design, compliance with 2MOOP/2MOPP within the framework of IEC 60601-1 can be achieved on the connector itself – saving the customer additional design effort for this part of his application.The developers at ODU are always busy further optimizing the product range – of course in close cooperation with the customers.ODU customers can rest assured that they are sourcing high-quality and safe connectors that meet the highest standards of medical technology.
For more information on how ODU deals with MDR, visit the website at https://odu-connectors.com/industries/medical/, watch our new video on the topic https://vimeo.com/871384902 or talk to our experts in person - for example, from 13.11.2023 to 16.11.2023 at Compamed in Düsseldorf, Germany, at booth P19/Hall 8a.
