Developing innovative medical devices that help everyone

Medical technology is one of the most innovative industries worldwide – about one third of the turnover is achieved with product developments of the last three years! In addition to short innovation cycles, the growing interdisciplinarity, the high complexity of research and development processes and increasingly strict regulatory requirements are among the special challenges. CONTACT Medical is an integrated industry solution for the special requirements of medical technology.

Advantages for enterprises and employees

  • Integrated project, process and documentation environment for the medical engineering industry designed according to the compliance in process principle
  • Clearly structured digital folders and audit-trail-compliant development documentation
  • Accelerated processes thanks to digital signatures and workflows
  • Efficient fulfillment of quality and compliance requirements
  • Unique role and permissions system and security concept

Mastering the lifecycle of a medical device

CONTACT Medical provides an integrated industry solution that takes account of the special requirements of the medical engineering industry. This offering promises to let you "master the lifecycle of a medical device". Medical combines requirements, data, documents, projects and processes and offers comprehensive validity and traceability in the entire development process with the principle of Single Source of Truth.

CONTACT Medical provides an integrated industry solution that takes account of the special requirements of the medical engineering industry. This offering promises to let you "master the lifecycle of a medical device". Medical combines requirements, data, documents, projects and processes and offers comprehensive validity and traceability in the entire development process with the principle of Single Source of Truth.

Reliable document management for maximum security

With its flexible folder and classification concept, CONTACT Medical Document Management provides a comprehensive classification system. Filing structures organize the entire documentation that is created during the product life cycle. This enables, for example, the fulfillment of the verification obligations specified by FDA 21 CFR and ISO 13485. Clear and easily adaptable inspection and approval workflows support smooth processes and ensure process quality and safety.

Reliable document management for maximum security

With its flexible folder and classification concept, CONTACT Medical Document Management provides a comprehensive classification system. Filing structures organize the entire documentation that is created during the product life cycle. This enables, for example, the fulfillment of the verification obligations specified by FDA 21 CFR and ISO 13485. Clear and easily adaptable inspection and approval workflows support smooth processes and ensure process quality and safety.

With its flexible folder and classification concept, CONTACT Medical Document Management provides a comprehensive classification system. Filing structures organize the entire documentation that is created during the product life cycle. This enables, for example, the fulfillment of the verification obligations specified by FDA 21 CFR and ISO 13485. Clear and easily adaptable inspection and approval workflows support smooth processes and ensure process quality and safety.

Accelerated release procedures and compliance in process

CONTACT Digital Signatures accelerates internal and external checking and approval procedures and makes them fully traceable. Any object such as products, bills of materials and documents can be digitally signed. The solution also supports the fulfillment of regulatory requirements (Electronic Records, FDA), ensures security and protects against fraud. With investigations of cause and effect, corrective measures and links to products and projects, medical technology manufacturers create transparency. CONTACT Medical supports companies in comprehensively fulfilling their documentation obligations as well as the requirements regarding material conformity, for example, according to REACH and RoHS. The principle: compliance in process − thanks to automatically running documentation, the effort required to fulfill the obligation to provide evidence is significantly reduced. 

 

CONTACT Digital Signatures accelerates internal and external checking and approval procedures and makes them fully traceable. Any object such as products, bills of materials and documents can be digitally signed. The solution also supports the fulfillment of regulatory requirements (Electronic Records, FDA), ensures security and protects against fraud. With investigations of cause and effect, corrective measures and links to products and projects, medical technology manufacturers create transparency. CONTACT Medical supports companies in comprehensively fulfilling their documentation obligations as well as the requirements regarding material conformity, for example, according to REACH and RoHS. The principle: compliance in process − thanks to automatically running documentation, the effort required to fulfill the obligation to provide evidence is significantly reduced. 

 

Efficient requirements and approval management

The FDA demands the complete recording and traceability of the requirements as well as their implementation. The integrated requirements management guarantees this! All requirements − including regulatory ones such as those from the battery or packaging ordinance − can be stored as a library and in project templates and then used quickly and easily in any project.

CONTACT Medical also provides efficient process support for the approval of medical devices on the international market. Almost every country has its own approval procedures due to a lack of international harmonization. With CONTACT Medical, medical device manufacturers can flexibly map the required test processes, test runs and other measures to the respective national specifications using workflow designers and template libraries. This support from CONTACT Medical also applies to re-audit and re-certification processes.

The FDA demands the complete recording and traceability of the requirements as well as their implementation. The integrated requirements management guarantees this! All requirements − including regulatory ones such as those from the battery or packaging ordinance − can be stored as a library and in project templates and then used quickly and easily in any project.

CONTACT Medical also provides efficient process support for the approval of medical devices on the international market. Almost every country has its own approval procedures due to a lack of international harmonization. With CONTACT Medical, medical device manufacturers can flexibly map the required test processes, test runs and other measures to the respective national specifications using workflow designers and template libraries. This support from CONTACT Medical also applies to re-audit and re-certification processes.

The link between the article structures and the document structures result in huge time savings in the change process.
Ronny Hübl
Head of the Project Management Office
Olympus Surgical Technologies Europe

Compliance in process: the most efficient way of managing processes and documents

Dr.-Ing. Regine Wolters, M.Sc. Medical Informatics
Analyst, Product Management & Consulting
CONTACT Software

Everything you need to ensure the compliance and security of your processes – CONTACT Elements

Use the world's most up-to-date platform and technology for the data management of virtual products, collaboration, and process and project management in the product engineering environment. CONTACT Elements helps you do this with a comprehensive application portfolio and a range of best practices. Like Lego, CONTACT Elements' modular design principle stands for solutions that are far more than the sum of their parts: each impressive in its own right – combined outstanding!

Get to know the CONTACT Elements applications better!

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