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Product Data Module

The Product Data Module transforms traditional technical documentation into a structured, data-driven environment. Instead of managing scattered Word documents and Excel files, CertHub provides a cohesive system where product data, documentation, and regulatory requirements work together seamlessly.

Product Overview The Product Module interface provides a structured way to manage all your product-related data and documentation.

Core Components​

The Product Module consists of four main building blocks, each serving specific regulatory needs:

1. Schema Libraries & Schemas (Templates)​

Schema Libraries group related schemas (templates) together based on regulatory requirements or business needs:

  • Libraries organize schemas by purpose (e.g., Risk Management, Clinical Evaluation)
  • Schemas define the structure for data collection
  • One schema can belong to multiple libraries
  • Libraries and schemas can be imported into products

Example Libraries:

  • Risk Management Library
  • Clinical Evaluation Library
  • Technical Documentation Library
  • Design Control Library

2. Products & Families (Data)​

Products and Product Families are where you actually store your data:

  • Product Families group related products and share common data
  • Products contain the actual device-specific information
  • Both use Knowledge Units and Topics to organize data
  • Can import schemas from multiple libraries to define their structure

Data Organization: From Templates to Actual Data​

Templates (Schemas)​

Schemas act as templates that define:

  • What data needs to be collected
  • How it should be structured
  • Which validation rules apply
  • Where the data can be reused

Actual Data Storage (Knowledge Units & Topics)​

Knowledge Units (KUs)​

Knowledge Units are the actual data containers within products and families:

  • Created based on schema templates
  • Organize related information in a tree structure
  • Enable inheritance from families to products
  • Maintain version control of your data
  • Can be reused across products

Knowledge Topics (KTs)​

Knowledge Topics are the individual data entries within Units:

  • Store the actual product information
  • Can be single-entry (e.g., Intended Use) or multi-entry (e.g., Product Variants)
  • Follow the structure defined in schemas
  • Support data validation and relationships

The relationship diagram shows how schemas define templates that are used to create actual data structures in products and families. Dotted lines show template relationships, solid lines show data containment.

Example: From Schema to Data​

Let's say you have a "Technical Documentation" schema:

  1. The schema defines that you need:

    • Intended Use (single entry)
    • Product Variants (multiple entries)
    • Risk Classification (single entry)

  2. When you create a product:

    • A Knowledge Unit is created based on this schema
    • Topics are created for each required data point
    • You fill in the actual data for your specific device

This way, the same schema can be reused across multiple products while ensuring consistent data collection.

Integration with MDKU​

The Product Module's data-driven approach is developed in collaboration with the Medical Device Knowledge Unit (MDKU), ensuring:

  • Industry best practices
  • Regulatory alignment
  • Standardized data structures
  • Efficient knowledge management

Getting Started​

Best Practice

Start with a well-defined schema structure before adding products. This ensures consistent data collection and makes it easier to maintain regulatory compliance across your product portfolio.

To begin implementing your product data management in CertHub:

  1. Set Up Your Schema Libraries

    • Create libraries based on regulatory needs
    • Define schemas with required data structures
    • Establish validation rules
    • Plan for data reuse

  2. Create Product Families

    • Group related products
    • Import relevant schemas
    • Set up shared Knowledge Units
    • Define common data

  3. Add Products

    • Create specific product entries
    • Link to appropriate families
    • Import additional schemas if needed
    • Fill in product-specific data

The following chapters provide detailed guides for: #2. Modules Overview/2. Product Module/managing-schemas

  • [Managing Schemas and Libraries](2. Modules Overview/2. Product Module/managing-schemas)
  • [Managing Products](2. Modules Overview/2. Product Module/managing-products)