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

Ensure Market Presence. Keep products on the market to stay competitive.

Enhance Innovation

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

Global Market Expansions

Navigate Regulations Effortlessly. Enter new markets with one-click submissions for EU MDR, FDA, and more

Quality Management & Regulatory Affairs Colleagues

Eliminate Manual Errors

Automate document handling and compliance tracking

Stay Audit-Ready

Real-time updates, integrated workflows, and centralized access keep you always prepared

Simplify Post-Market Surveillance

Automate data gathering and reporting for easy compliance management

Excellence Across Teams

Keep quality and operations teams aligned and stay connected with all departments

Cut Compliance Time in Half

Automate repetitive tasks like documentation updates to save time and effort

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 delayed by limited Notified Body capacity and strict MDR regulations.

Risk of product discontinuation

Struggling with legacy product compliance under MDR, risking phase-out.

Innovation stagnation

Regulatory burdens divert resources from R&D and innovation.

Global competition

European companies face slower time-to-market, risking market share loss to competitors in less regulated regions.

Our Solutions

Automated compliance workflows

CertHub streamlines the regulatory process, reducing manual work 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 docs in one place for easy access and audits.

Global regulatory alignment

CertHub supports multiple standards, enabling 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.

‎ ‎

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 documentation handling causes errors and redundancies, raising compliance risks.

Overburdened teams

Inefficient processes waste time, hindering productivity and slowing strategic quality improvements.

Lack of standardization

Disconnected tools and inconsistent workflows delay 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 submissions, minimizing manual errors.

Standardized workflows

Ensure Consistency. Use pre-built templates to export SOPs and workflows that meet 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

Centralize Compliance Docs. Manage all documentation in one platform for transparency across teams.

Benefits & Savings

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

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

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

‎ ‎

Prepare for audits 2x faster with centralized, up-to-date documentation.

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

Product Team

Challenges

Knowledge gaps

Regulatory expertise gaps make aligning technical development with compliance difficult.

Complex documentation

Manual documentation is overwhelming, prone to errors, and slows down progress.

Version control issues

Keeping updates consistent across multiple documents and versions is labor-intensive.

Time-consuming compliance tasks

Compliance tasks like documentation distract from core engineering work, consuming significant time.

Lack of intuitive tools

Regulatory tools are often not user-friendly, creating steep learning curves for engineers.

Our Solutions

Embedded compliance checks

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

Automated documentation and traceability

Auto-update technical documents to ensure ongoing compliance.

Version control made easy

CertHub ensures smooth tracking and version control, reducing errors and maintaining consistency.

Simplified processes

ngineers focus on innovation while CertHub manages regulatory complexity in the background.

User-friendly interface

CertHub’s intuitive design simplifies compliance, reducing the learning curve 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.

‎ ‎

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.

logo

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

© CertHub 2024