Confideck Ecosystem: Tailored Solutions for Manufacturers, Notified Bodies, and Consultancies

Automated TD processes

Automate the creation and maintenance of compliance-ready technical files, reducing time spent and minimizing errors.

Quality & project control

Keep all regulatory documents centralized in a secure platform, ensuring seamless collaboration and project oversight.

Pre-submission validation

identify and resolve non-conformities with automated checks aligned to industry standards, ensuring submission readiness.

Compliance management

Accelerate certification timelines and maintain regulatory compliance with tools designed to simplify and optimize the entire process.

Pre-checked submissions

Our solution ensures your technical files are validated and ready for submission, reducing review complexity and expediting the NB approval process.

Structured file management

Receive technical files formatted and organized specifically to meet NB requirements, allowing for efficient navigation and review of critical compliance data.

Efficient Communication

Enable efficient collaboration with stakeholders, resolving any non-conformities quickly and keeping certification timelines in sight.

Project control

Track the progress of reviews in real-time, ensuring clarity on the status of certifications and reducing uncertainty during the review process.

Efficient client management

Manage technical documentation for multiple clients with secure and efficient processes in a dedicated platform.

Seamless collaboration

Facilitate smooth collaboration with manufacturers through shared workspaces for coordinated reviews and streamlined feedback.

Supercharged consulting

Optimize your templates with built-in automations and automated error checks, saving time and ensuring compliance.

Audit-Ready Support

Prepare client documentation for regulatory inspections with full traceability and centralized control.

FAQ

What is the Confideck Initiative?

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?

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?

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?

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?

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?

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

Tailored option for the entire ecosystem.

A purpose-built solution by and for the industry.