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CertHub for instantly fast and continuous compliance.

C-levels/Managers

Maximize your ROI

Reduce regulatory compliance costs by up to 30%

Faster Time to Market

Accelerate product launches by cutting through complex regulatory hurdle

Protect Your Bottom Line

Make sure your products always stay on the market to secure your market position

Enhance Innovation

Free up resources for R&D by reducing the time and effort spent on compliance

Global Market Expansions

Seamlessly navigate international regulations (EU MDR, FDA) and confidently enter new markets with CertHub’s one-click submission

Quality Management & Regulatory Affairs Colleagues

Eliminate Manual Errors

Automate document handling and compliance tracking

Stay Audit-Ready

Always be prepared for audits with real-time document updates, integrated workflows, and centralized access

Simplify Post-Market Surveillance

Effortlessly manage post-market surveillance requirements with automated data gathering and reporting tools

Excellence Across Teams

Ensure consistency between the quality and operation teams and always stay connected to other departments

Cut Compliance Time in Half

Free up valuable resources by automating repetitive tasks like documentation updates.

Product Team

Bridge the Knowledge Gap

Gain instant access to clear regulatory guidance and always stay updated.

Reduce Documentation Complexity

Simplify complex technical documentation with intuitive templates

Streamline Workflows

Save time with working on just one platform

Ensure Compliance from the Start

Meet all regulatory requirements from the start of the development process.

Effortless Version Control

Keep track of all changes with robust version control and automatic updates.

C-levels/Managers

Challenges

Rising costs

Regulatory compliance has increased manufacturing significantly eating into profits.

Delayed market entry

Product approvals are slow due to Notified Bodies’ limited capacity and stringent MDR regulations​.

Risk of product discontinuation

Struggling to keep legacy products compliant under MDR, leading to potential product phase-out​.

Innovation stagnation

Regulatory burdens make it harder to allocate resources for R&D and innovation.

Global competition

European companies face slower time-to-market, risking market share loss to competitors in regions with easier regulatory environments.

Our Solutions

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Automated compliance workflows

CertHub streamlines the entire regulatory process, minimizing manual intervention and errors.

Integrated submissions

One-click solutions for MDR and FDA submissions reduce complexity and time.

Real-time monitoring

Stay ahead of regulatory requirements with proactive compliance checks and alerts.

Centralized documentation

Keep all regulatory and quality documents in one place for easy access and audit readiness.

Global regulatory alignment

CertHub supports multiple market standards, allowing seamless expansion into new regions.

Benefits & Savings

Cut compliance costs by 30% by automating labor-intensive regulatory tasks.

Accelerate time-to-market by 40%, getting your products approved faster.

Reduce product recalls by 50% with continuous compliance monitoring and proactive risk management.

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Boost operational efficiency by 25%, reallocating resources towards innovation and growth.

Expand globally 3x faster by leveraging CertHub’s integrated submission features for FDA and MDR compliance.

Quality Management & Regulatory Affairs

Challenges

Manual errors

Manual handling of documentation leads to frequent errors and redundancies, increasing compliance risks​

Overburdened teams

Time-consuming, inefficient processes hinder productivity and reduce focus on strategic quality improvements​

Lack of standardization

Disconnected tools and inconsistent workflows slow down regulatory submissions and audits

Post-market surveillance burden

Continuous monitoring and reporting are manual and resource-intensive​

Our Solutions

Automated documentation

CertHub automates document management and regulatory submissions, reducing manual errors.

Standardized workflows

Ensure consistency with pre-built templates s to Export SOPs and workflows that align with regulatory requirements.

Real-time updates

Stay audit-ready with live document updates and compliance tracking.

Seamless post-market surveillance

Automated reporting and workflows to streamline post-market compliance.

Centralized access

Manage all compliance documentation in one easy-to-navigate platform, ensuring transparency across teams.

Benefits & Savings

Reduce manual errors by 70% with automated workflows and real-time compliance tracking.

Cut compliance effort by 50%, freeing up time for strategic quality initiatives.

Achieve 100% consistency across documentation with standardized templates and processes.

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Prepare for audits 2x faster with centralized, always-updated documentation.

Save 40% of time spent on post-market surveillance with automated reporting and tracking.

Product Team

Challenges

Knowledge gaps

Product team often lack deep regulatory expertise, making it hard to align technical development with compliance standards​.

Complex documentation

Technical documentation is overwhelming and difficult to maintain manually, leading to errors and slowdowns.​

Version control issues

Maintaining consistent, traceable updates across multiple documents and product versions is labor-intensive.

Time-consuming compliance tasks

Compliance tasks such as documentation are seen as a distraction from core engineering tasks​ which takes significant. time

Lack of intuitive tools

Many regulatory and documentation tools are not user-friendly, creating steep learning curves for engineers​.

Our Solutions

Embedded compliance checks

CertHub integrates compliance directly into the engineering workflow, simplifying regulatory adherence.

Automated documentation and traceability

Automatically update technical documents to ensure compliance throughout product development.

Version control made easy

CertHub ensures seamless tracking and version control, reducing errors and ensuring consistency.

Simplified processes

Engineers can focus on innovation while CertHub handles the regulatory complexity in the background.

User-friendly interface

CertHub’s intuitive design reduces the learning curve, making compliance easier to navigate for engineers.

Benefits & Savings

Reduce documentation complexity by 60% with automated traceability and clear workflows.

Cut compliance effort by 50%, freeing engineers to focus on innovation.

Boost engineering productivity by 35% by eliminating repetitive admin tasks and ensuring compliance in real-time.

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Ensure 100% traceability across all versions with automated updates and centralized document management.

Shorten product development cycles by 40% by integrating compliance processes directly into the engineering workflow.

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CertHub offers software for digital QMS and Technical Documentation to enable medical device manufacturers to launch their products years faster.

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