CIM Database Medical
Re-audit Re-certification
Market Monitoring
Market Launch
Quality and Compliance Management Regulatory Approval
Development
Idea and Technical Feasibility
Requirements Engineering
contact software
Project and Process Management Product Data Management Document Management
regarding material conformity, for example, according to REACH and RoHS. The principle: Compliance in Process – thanks to automatically running documentation, the effort required to fulfil the obligation to provide evidence is significantly reduced.
Efficient management of requirements and approval The FDA demands the complete recording and traceability of 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. CIM Database 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 harmonisation. With CIM Database 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 CIM Database Medical also applies to re-audit and re-certification processes.
Guide to german Medtech companies 2021
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