A high-tech technical documentation platform.

In collaboration with Auditors, manufacturers, and industry experts.
Automate compliance.
Accelerate innovation.
The future of compliance is automated.
Future-proof system
Stay ahead of evolving requirements with a system designed to support documentation for MDR, IVDR, and global compliance requirements.
Automated compliance
Reduce manual and error prone work with purpose-built automation tools, adaptable to internal operational and documentation processes.
Compliance control
Seamlessly collaborate across teams with tools designed for PRRCs, R&D, and QA professionals, ensuring accuracy and quality.
Global scalability
Built for European manufacturers with the flexibility to scale globally, supporting compliance needs in every market.
Advanced automation
Specialized automation modules for every step in your technical documentation lifecycle - from creation to submission and maintenance. With specialized automation modules designed to eliminate repetitive tasks and ensure compliance with ease, giving your team more time to focus on innovation.
  • Document and data-based automation
  • Cross-documentation automation
  • Global requirement configurations
Error & compliance control
Detection of cross-document issues and identification of compliance risks at every step. Maintain accuracy, reduce errors, and streamline reviews, approvals, and submissions while ensuring quality control.
  • Impact assessments
  • Error & completeness checks
  • Compliance radar
Enterprise platform
Manage your technical documentation with confidence. Confideck ensures all documents remain secure, compliant and accessible. Stay in control with advanced tracking, real-time oversight and leading security standards.
  • Quality control & project oversight
  • Use pre-existing documentation
  • Full control, security, and oversight

Take control of your compliance processes. Now.

Connect
Book a consultation to share your compliance goals and explore how Confideck can simplify your documentation process.
Set up
Easily integrate Confideck with your existing documentation. Our experts are here to support for tailored configurations.
Accelerate
Immediate results: Simplified maintenance & submissions, efficient collaboration and compliance tracking from day one.
Talk to our experts
A solution designed in collaboration with manufacturers and auditors.
Confideck´s development and operational processes align with industry standards such as:
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ISO 13485
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ISO 27001
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ISO 80002-2
FAQ
What is the Confideck Initiative?
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The Confideck Initiative is a European-driven effort uniting high-tech innovation with deep regulatory expertise to simplify compliance for the medical device and in-vitro diagnostic industries. Our mission is to empower manufacturers with advanced, reliable solutions that accelerate certification and support innovation.
What is Confideck’s platform?
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Confideck’s platform is designed for medical device and in-vitro diagnostic manufacturers to simplify technical documentation. Combining enterprise-grade compliance, seamless MS Office integration, and user-friendly automation, Confideck streamlines regulatory processes for faster and more reliable outcomes.
How does Confideck help reduce manual work?
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Confideck’s automation tools eliminate repetitive tasks, minimize errors, and accelerate (re)certification processes. By automating critical steps, Confideck frees your team to focus on driving innovation and meeting core business goals.
Where are the servers located?
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Our servers are located exclusively within the European Union (Germany), compliant with GDPR and other relevant data protection regulations. Certified to ISO 27001, ISO 27017, ISO 27018, and ISO 9001 standards, we prioritize your data security and operational integrity.
Is Confideck suitable for my company?
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Confideck caters to companies of all sizes, from global enterprises to growing startups. Built on adaptable configurations, our platform scales to meet your unique needs while delivering value across industries.
Is the software validated?
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Confideck software is fully verified to meet stringent quality and compliance standards. Our team is available to assist with your validation efforts, ensuring seamless integration into your processes.
Do you have any questions about how Confideck can transform your regulatory documentation?
Get in touch