CONTACT Medical ensures that documentation can be stored in a way that is audit-trail capable and plays a considerable role in ensuring that we are able to fully meet compliance requirements.Ronny Hübl
Head of the Project Management Office
Olympus Surgical Technologies Europe
- Document, project and process management that is tailored to the requirements of the medical engineering industry
- Efficient fulfillment of quality and compliance requirements
- Audit trail for documents and items
- Support during the automatic creation of document folders relevant to product approval and their PDF export
- Integration of industry standards like workflows and digital signatures
Manufacturers of medical products must be able to ensure beyond doubt the quality of their products and processes and be able to prove this in ever greater detail. CONTACT Medical offers an integrated project, process and documentation environment designed according to the principle of compliance in process: From the initial product requirements through to regulatory approval, as well as in the case of changes or re-audits, valid, verifiable and complete data and documents are recorded directly in the context of the project and release processes. This ensures that compliance with regulatory requirements throughout the entire product lifecycle can be achieved faster and with significantly less effort.
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