Developing innovative medical devices that help everyone

The medical engineering industry is one of the most innovative industries in the world – approximately one-third of its sales are generated by products developed in the past three years. In addition to short innovation cycles, the particular challenges being faced include an increasingly interdisciplinary approach, the extreme complexity of research and development processes and ever-stricter regulatory requirements regarding the products and processes.

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

Central data source is the key to success
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 incorporates requirements, data, documents, projects and processes and, as a central source of data, offers comprehensive validity control and traceability throughout the entire development process.

Central data source is the key to success
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 incorporates requirements, data, documents, projects and processes and, as a central source of data, offers comprehensive validity control and traceability throughout the entire development process.

Easy and reliable document management

Highly secure document management
With its flexible folder and classification concept, CONTACT Medical's document management facility provides a reliable organizational system. The solution organizes all the documents created throughout the product lifecycle in secure file structures. It thus allows the obligations to ensure traceability stipulated in FDA 21 CFR and ISO 13485 to be met, for example.
Flexible testing and approval workflows help make sure that everything runs smoothly and ensure process quality and process reliability from the start.

  • Development documentation history
    Logging the change history by means of an audit trail, i.e. creating seamlessly traceable documentation by chronologically recording the relevant changes made to files, documents and records (for example, conformity with the FDA requirement 21 CFR, Design History File)

  • Digital document folders
    Overview and transparency thanks to folders for storing all the documents relating to a product, e.g. all the documents required for the approval of a medical device

Easy and reliable document management

Highly secure document management
With its flexible folder and classification concept, CONTACT Medical's document management facility provides a reliable organizational system. The solution organizes all the documents created throughout the product lifecycle in secure file structures. It thus allows the obligations to ensure traceability stipulated in FDA 21 CFR and ISO 13485 to be met, for example.
Flexible testing and approval workflows help make sure that everything runs smoothly and ensure process quality and process reliability from the start.

  • Development documentation history
    Logging the change history by means of an audit trail, i.e. creating seamlessly traceable documentation by chronologically recording the relevant changes made to files, documents and records (for example, conformity with the FDA requirement 21 CFR, Design History File)

  • Digital document folders
    Overview and transparency thanks to folders for storing all the documents relating to a product, e.g. all the documents required for the approval of a medical device

Highly secure document management
With its flexible folder and classification concept, CONTACT Medical's document management facility provides a reliable organizational system. The solution organizes all the documents created throughout the product lifecycle in secure file structures. It thus allows the obligations to ensure traceability stipulated in FDA 21 CFR and ISO 13485 to be met, for example.
Flexible testing and approval workflows help make sure that everything runs smoothly and ensure process quality and process reliability from the start.

  • Development documentation history
    Logging the change history by means of an audit trail, i.e. creating seamlessly traceable documentation by chronologically recording the relevant changes made to files, documents and records (for example, conformity with the FDA requirement 21 CFR, Design History File)

  • Digital document folders
    Overview and transparency thanks to folders for storing all the documents relating to a product, e.g. all the documents required for the approval of a medical device

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

Digital signatures for all object types
The digital signature solution allows for significant acceleration and seamless traceability of internal and external testing and approval processes. Any object (product, BOM, document, project plan, etc.) and its associated metadata can be digitally signed. The digital signature solution also supports compliance with regulatory requirements (electronic records, FDA), ensures security, protects against fraud and saves money by dispensing with costs for paper, printing and distribution.

Quality and compliance management
Components such as CAPA (Corrective and Preventive Actions) and FMEA (Failure Mode and Effects Analysis) enable medical device manufacturers to fulfill quality assurance requirements. Elements such as the analysis of cause and effects, corrective measures and links to products and projects according to the principle of compliance in process are easy to configure. In addition to ensuring process and document compliance, CONTACT Medical also ensures that material compliance requirements (e.g. REACH, RoHS) are met.

Digital signatures for all object types
The digital signature solution allows for significant acceleration and seamless traceability of internal and external testing and approval processes. Any object (product, BOM, document, project plan, etc.) and its associated metadata can be digitally signed. The digital signature solution also supports compliance with regulatory requirements (electronic records, FDA), ensures security, protects against fraud and saves money by dispensing with costs for paper, printing and distribution.

Quality and compliance management
Components such as CAPA (Corrective and Preventive Actions) and FMEA (Failure Mode and Effects Analysis) enable medical device manufacturers to fulfill quality assurance requirements. Elements such as the analysis of cause and effects, corrective measures and links to products and projects according to the principle of compliance in process are easy to configure. In addition to ensuring process and document compliance, CONTACT Medical also ensures that material compliance requirements (e.g. REACH, RoHS) are met.

Easily manage any type of requirement

Project and process management
Due to the large number regulatory requirements that have to be met, numerous testing and approval processes have to be performed in every development project. Medical's project management facility makes it easy to map traceable and audit-trail-compliant workflows using the Workflow Designer. The graphic modeling of business processes is characterized by easy operation thanks to freely definable processing rules. Direct links to pending tasks and documents that require processing allow for a structured flow of information and ensure efficient workflows. Special workflows for digital signatures mean that companies can benefit twofold from the process acceleration brought about by CONTACT Medical and drive innovative projects forward effectively.

Requirements management
The FDA already demands the recording of requirements and the seamless traceability of their implementation. The requirements management capability integrated in CONTACT Medical ensures that you can meet these demands. All requirements – even regulatory requirements such as those stipulated in the battery and packaging ordinances for example – can be stored as a library and in project templates and then be instantiated quickly and easily. Furthermore, relationships can be established between requirements and functions, components, and project tasks according to the principle of compliance in process – thus allowing their level of fulfillment to be assessed.

Approval management
CONTACT Medical provides effective support in the context of the approval process for medical devices on the international market. Due to a lack of international harmonization, almost every country has its own system for categorizing medical devices and its own approval processes. By flexibly mapping the requisite testing processes, test runs and other measures with the Workflow Designer and providing support in the form of template libraries, Medical enables the respective national requirements to be fulfilled. CONTACT Medical provides the same level of support for re-audit and re-certification processes.

Project and process management
Due to the large number regulatory requirements that have to be met, numerous testing and approval processes have to be performed in every development project. Medical's project management facility makes it easy to map traceable and audit-trail-compliant workflows using the Workflow Designer. The graphic modeling of business processes is characterized by easy operation thanks to freely definable processing rules. Direct links to pending tasks and documents that require processing allow for a structured flow of information and ensure efficient workflows. Special workflows for digital signatures mean that companies can benefit twofold from the process acceleration brought about by CONTACT Medical and drive innovative projects forward effectively.

Requirements management
The FDA already demands the recording of requirements and the seamless traceability of their implementation. The requirements management capability integrated in CONTACT Medical ensures that you can meet these demands. All requirements – even regulatory requirements such as those stipulated in the battery and packaging ordinances for example – can be stored as a library and in project templates and then be instantiated quickly and easily. Furthermore, relationships can be established between requirements and functions, components, and project tasks according to the principle of compliance in process – thus allowing their level of fulfillment to be assessed.

Approval management
CONTACT Medical provides effective support in the context of the approval process for medical devices on the international market. Due to a lack of international harmonization, almost every country has its own system for categorizing medical devices and its own approval processes. By flexibly mapping the requisite testing processes, test runs and other measures with the Workflow Designer and providing support in the form of template libraries, Medical enables the respective national requirements to be fulfilled. CONTACT Medical provides the same level of support for 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 – powered by CONTACT Elements

Powered by CONTACT Elements means that you 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. CIM Database 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 CIM Database applications better!

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