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What is the medical device technical file? What should it contain and how should it be structured? ...
Document controls
Bring order to your development, ensure documents are created, approved, distributed, indexed, and archived in a solid and systematic way.
Version control
Change management
Audit trails
Configurable approval workflows
Metadata indexing
Integrated e-signatures (FDA 21 CFR Part 11 compliant)
Design controls
Gather and control your design inputs and outputs in one place, stage gate your processes to continually validate designs and manage risk. Automate and bulletproof your design documentation for frictionless compliance:
Flexible phase gating
Design validation
Assemble FDA technical documentation in real-time (DHF, DHR, DMR)
Quality modules
A configurable suite of features to manage your quality processes to drive continuous improvement and seamless regulatory compliance:
Training matrices
Complaints handling
Non-conformance reports
CAPA forms
Post market surveillance
Compliance
All the tools you need to gain ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 11, but flexible and configurable. Cognidox helps compliance become the ‘way you do things’.
Assemble required technical documentation in real-time
Publish DHF, DHR and DMR on demand
Integrate FDA compliant E-signatures
CAPA reporting built around the way you work
Software validation
Cognidox helps you rapidly migrate from paper, Google Docs or OneDrive, to a structured document management system. We’ve helped hundreds of businesses bring their documents and process under control, helping them innovate faster and repeat development success time and again.
Starting with an obligation-free demo, if we’re the right fit for you we’ll offer a 60 day free trial of our platform. When you choose us as your partner, we’ll help you migrate data and configure the platform, with a dedicated account manager to look after you as you grow.
See if Cognidox can help you by scheduling a no-obligation, tailored demo
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Set up a free 60 day live trial to test the solution with real users and processes
We’ll help you configure your system, migrate your data and train your team
A dedicated Account Manager will support you as you scale (our average response time is under 20 minutes)
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