With the Medical Device Regulation (MDR) coming into force in May 2021, the requirements for manufacturers placing medical devices on the EU market have changed. It is advantageous if certified qualification and validation information is available early on in the supply chain.
The directive aims to increase the quality and traceability of medical devices. To this end, it influences the processes involved in manufacturing the products and entails additional testing and documentation work. This is because the MDR's objective of increasing patient and user safety with flawless medical devices can only be achieved by obliging manufacturers of medical devices to fulfill all relevant regulatory requirements before they place their product on the market. The requirements do not only apply to the medical device itself. The technical documentation, classification, approval and other topics must also be covered.
As a supplier of connectors for medical applications, ODU therefore also saw itself as having a duty here - because connectors, cables and housings for diagnostics, therapy or monitoring are relevant parts of medical products. Even as preliminary products, they must meet the requirements of the MDR.
"In order to support our customers with complete technical documentation, we have DIN EN 13485:2016-certified qualification and validation information," says Mathias Wuttke, Business Development Manager for the medical technology sector. The documents include product information in the form of technical data sheets, test reports and labeling of products or assemblies.
"As ODU, we also pay attention to issues such as patient and user protection for our products and use them in compliance with IEC 60601-1. We are also able to implement Unique Device Identification (UDI) by laser marking our connectors," says Wuttke. The supplier also communicates relevant changes to its customers in the event of changes to products that require a new risk assessment. "We have set up a dedicated office within the company for this purpose, which is the point of contact for manufacturers' inquiries and provides information."
The connector specialist's contribution is achieved with an end-to-end risk and quality management system and offers appropriate support for customers
- for complete traceability
- in post-market surveillance in order to derive necessary corrective and preventive measures at a later date
- when considering the entire product life cycle and
- for the responsible person of the distributor and the customers from the medical sector.
The company is one of the leading international suppliers of connector systems and employs around 2500 people worldwide. The ODU Group is headquartered in Mühldorf a. Inn. Further production and product development sites are located in Sibiu/Romania, Shanghai/China, Tijuana/Mexico and Camarillo/USA.
The company combines all relevant competencies and key technologies for design and development, tool and special machine construction, injection molding, stamping, turning, surface technology, assembly and cable assembly under one roof.
The group of companies is represented globally with its products and has an international sales network. This includes its own sales companies in China, Denmark, Germany, France, Hong Kong, Italy, Japan, Korea, Romania, Sweden, the UK and the USA, as well as numerous worldwide sales partners.
In addition to medical technology, ODU connectors ensure the reliable transmission of power, signals, data and media in numerous other demanding areas of application - for example in industrial electronics or measurement and testing technology, in automotive applications and in military and security technology.
