CONTACT Medical – Medical engineering solutions for your needs
In medical engineering, the speed of innovation determines market success. One-third of revenue comes from products that are less than three years old. Manufacturers therefore need PLM software that accelerates their increasingly complex interdisciplinary research and development processes while meeting strict regulations.
CONTACT Medical was specifically developed for these needs. The PLM solution automates documentation and seamlessly integrates quality management into your development processes. This way, you benefit from faster development cycles while guaranteeing safety – from the first idea to market approval.
Olympus Surgical Technologies Europe is a manufacturer of high-quality medical engineering for minimally invasive surgery. The high-tech specialist meets its extensive compliance requirements with the help of CONTACT Medical.
Olympus Surgical Technologies Europe is a manufacturer of high-quality medical engineering for minimally invasive surgery. The high-tech specialist meets its extensive compliance requirements with the help of CONTACT Medical.
Olympus Surgical Technologies Europe is a manufacturer of high-quality medical engineering for minimally invasive surgery. The high-tech specialist meets its extensive compliance requirements with the help of CONTACT Medical.
“The linking of item and document structures brings enormous time advantages in the change process.”
Ronny Hübl, Head of Project Management Office at Olympus Surgical Technologies Europe
CONTACT Medical is specifically tailored to the needs of the medical engineering sector and meets the highest standards and compliance requirements. Based on CIM Database PLM, CONTACT medical combines over 35 years of PLM expertise with extensive medical engineering know-how in a customized industry solution. Companies can therefore manage the entire lifecycle of their medical devices – from the first idea to market launch. As a central data platform, it connects requirements, data, documents, projects, and processes for all stakeholders into a reliable single source of truth. This way, manufacturers ensure full validity and traceability throughout the entire development process. Thanks to the underlying CONTACT Elements platform, the industry solution can be flexibly expanded by adding additional applications.
CONTACT Digital Signatures ensures secure and transparent review and approval processes through the use of digital signatures. Whether products, bills of materials, or documents – sign any objects legally, comply with regulatory requirements such as Electronic Records and FDA standards, and protect yourself against tampering with traceable documentation.
With our industry solution, medical engineering manufacturers can effortlessly meet all documentation requirements and obligations for material compliance according to REACH and RoHS in one system. The intelligent linking of material databases and product components makes material usage fully traceable and offers comprehensive analysis capabilities. This ensures full transparency over the materials used and guarantees compliant material selection – for products that are both regulation-compliant and environmentally friendly.
CONTACT Document Management offers an intelligent organizational system. With its flexible folder and classification concept, the entire product documentation can be organized and clearly stored throughout the entire product lifecycle. This also helps to meet the documentation requirements specified by FDA 21 CFR and ISO 13485. Clear, easily adaptable review and approval workflows guarantee smooth operations with maximum process quality and security.
The integrated requirements management of CONTACT Medical ensures that medical engineering manufacturers document and implement all FDA requirements comprehensively and traceably. All requirements, including regulatory requirements such as battery or packaging regulations, can be stored as templates. This simplifies both approval and re-certification processes as well as re-auditing for manufacturers by allowing them to adapt all required measures flexibly to the various requirements using workflows and template libraries.
The modular CONTACT Elements platform scales incrementally into a comprehensive solution, covering the entire lifecycle from initial idea to product development, manufacturing, and after-sales. Modern technologies you may only need in a few years can be added as needed.
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