With its flexible folder and classification concept, CONTACT 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 review and approval workflows support smooth processes and ensure process quality and safety.

CONTACT Digital Signatures accelerates internal and external checking and approval proc edures 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.

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. 

The FDA demands the complete recording and traceability of the requirements as well as of their implementation. The integrated requirements management guarantees this. All requirements - including regulatory ones such as battery or packaging regulations - can be stored as project templates.

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 review 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-audits and re-certification processes.