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Introduction to CertHub

The Challenge of Regulatory Compliance​

Ensuring regulatory compliance is essential for medical device manufacturers, but it is often a time-consuming and complex process. Teams must maintain alignment between Quality Management System (QMS) processes and Technical Documentation (TechDoc) while ensuring accuracy, traceability, and compliance with standards such as MDR, IVDR, and FDA regulations. However, traditional methods create significant challenges:

Manual Documentation Issues: Errors and Redundancies​

  • Inconsistencies and redundancies across multiple documents lead to confusion and errors.
  • The high interconnectivity between data in different documents is difficult to maintain and track properly.
  • Compliance-related tasks require significant manual effort, increasing the risk of human error and inefficiencies.

Failure to Implement Quality Processes: Root Causes of Errors​

  • Regulatory requirements are often not executed as intended, making adherence in daily operations challenging.
  • Lack of clear communication between teams (QA and production or engineering) leads to misunderstandings and misalignment in compliance efforts.
  • Defining lean compliance strategies with minimal overhead is difficult, as many teams lack the knowledge to establish necessary processes and tools effectively.

Inefficient Manual Workflows​

  • Compliance efforts are heavily reliant on manual, repetitive tasks, leading to wasted time and redundancies.
  • Teams struggle to keep documents up to date, causing misalignment in compliance reporting.

Lack of Traceability & Version Control​

  • Regulatory compliance requires full traceability of all changes, but traditional methods make tracking difficult.
  • Without a single source of truth (SSOT), outdated references and inconsistencies create audit risks.

Disjointed Quality & Engineering Data​

  • Compliance-critical information is scattered across SOPs, TechDocs, and verification documents, making it hard to ensure alignment.
  • Engineering and quality teams work in silos, leading to miscommunication and inefficiencies.

Slow & Fragmented Approvals​

  • Regulatory submissions require multiple approvals, but inefficient processes lead to delays.
  • Manual signature and review processes slow down compliance workflows, increasing the risk of non-compliance.

How CertHub Solves These Problems​

CertHub is a digital compliance platform that automates regulatory documentation by intelligently collecting and structuring compliance-relevant data from both Quality Management and Engineering processes. By applying smart automation, CertHub reduces administrative burdens, improves data integrity, and ensures regulatory consistency.

With CertHub, you can:

  • Define Processes, Data Inputs, and Automated Workflows
    Automate compliance data collection, structuring, and linking to documentation.
  • Ensure Full Traceability & Versioning
    Track every change in real-time with audit-ready version history.
  • Bridge QMS and Technical Documentation
    Unify quality processes with structured documentation to eliminate redundancies.
  • Utilize Pre-Built Regulatory Templates for Guidance
    Industry-standard templates simplify compliance while remaining fully customizable.

A Fully Customizable Compliance Solution​

What is very important to acknowledge is that nothing in CertHub is hardcoded—our system is designed to adapt to your organization’s unique needs. Users can customize workflows, input formats, document structures, and compliance processes to align with their regulatory strategy while maintaining automation, consistency, and audit readiness.

CertHub reduces compliance complexity, allowing MedTech companies to focus on innovation instead of documentation.